CALLOS IMPACT AND INJECT BONE VOID FILLER— 510(k) K051123
Substantially EquivalentSkeletal Kinetics, LLC
FDA 510(k) clearance K051123 for CALLOS IMPACT AND INJECT BONE VOID FILLER, Substantially Equivalent on 2005-06-03. Applicant: Skeletal Kinetics, LLC. Device class: 2.
Clearance details
- Applicant
- Skeletal Kinetics, LLC
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cupertino, CA, US
Recent devices under product code MQV
view allMore clearances from Skeletal Kinetics, LLC
view allAdverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K051123
K-number listed on FDA's recall record- Z-2592-2020 — ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
- Z-2593-2020 — ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
- Z-2594-2020 — ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
- Z-2606-2020 — EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
- Z-2607-2020 — EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
- Z-2610-2020 — MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
- Z-2611-2020 — MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
- Z-2620-2020 — OSTEOVATION, 5CC, INJECT FORMULA. Product Number: 390-2005, UDI: 813845020054 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
- Z-2621-2020 — OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
- Z-2622-2020 — OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
- Z-2623-2020 — OSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
- Z-2180-2020 — OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Z-2181-2020 — OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Z-2182-2020 — OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Z-2183-2020 — OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Z-2184-2020 — OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Z-2209-2015 — InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty 1.0 sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, a Mixing System, Targeting K-Wires and a Delivery Needle (Cannula). Model number 10801210. InjectionPlasty 1.0 is indicated to fill bony voids or gaps of the skeletal system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051123.
Data sourced from openFDA. This site is unofficial and independent of the FDA.