IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF
FDA 510(k) clearance K083798 · decided 2010-05-19
Clearance details
- K-number
- K083798
- Device name
- IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF
- Applicant
- Medicrea Technologies
- Decision
- Substantially Equivalent
- Date received
- 2008-12-22
- Decision date
- 2010-05-19
- Days to decision
- 513 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Douglassville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervert recall (Z-2453-2023) | Medicrea International | 2023-08-24 |
| IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B1 recall (Z-2457-2023) | Medicrea International | 2023-08-24 |