SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR— 510(k) K010690
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K010690 for SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR, Substantially Equivalent on 2001-05-18. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code DZL
- Device class
- Class 2
- Regulation
- 21 CFR 872.4880
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paoli, PA, US
Recent devices under product code DZL
view allMore clearances from Synthes (Usa)
view all- K141527 — DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
- K131984 — SYNTHES SYNSONIC ULNA NAIL
- K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
- K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEM
- K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
Adverse events under product code DZL
product code DZL- Injury
- 168
- Total
- 168
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 K010690
K-number listed on FDA's recall record- Z-1745-2013 — Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.
- Z-0903-2013 — Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
- Z-0904-2013 — Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
- Z-0905-2013 — Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010690.
Data sourced from openFDA. This site is unofficial and independent of the FDA.