AFT— 510(k) K042125
Substantially EquivalentMusculoskeletal Transplant Foundation
FDA 510(k) clearance K042125 for AFT, Substantially Equivalent on 2005-07-28. Applicant: Musculoskeletal Transplant Foundation. Device class: 2.
Clearance details
- Applicant
- Musculoskeletal Transplant Foundation
- 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
- Traditional
- Location
- Edison, NJ, US
Recent devices under product code MQV
view allMore clearances from Musculoskeletal Transplant Foundation
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 K042125
K-number listed on FDA's recall record- Z-1066-2024 — AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
- Z-1067-2024 — AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
- Z-2004-2016 — Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042125.
Data sourced from openFDA. This site is unofficial and independent of the FDA.