IMPIX LUMBAR INTERBODY DEVICE
FDA 510(k) clearance K100544 · decided 2010-07-22
Clearance details
- K-number
- K100544
- Device name
- IMPIX LUMBAR INTERBODY DEVICE
- Applicant
- Medicrea Technologies
- Decision
- Substantially Equivalent
- Date received
- 2010-02-25
- Decision date
- 2010-07-22
- Days to decision
- 147 days
- Clearance type
- Special
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Round Rock, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124 recall (Z-2455-2023) | Medicrea International | 2023-08-24 |