IMPIX MANTA CERVICAL INTERBODY DEVICE
FDA 510(k) clearance K100484 · decided 2010-03-16
Clearance details
- K-number
- K100484
- Device name
- IMPIX MANTA CERVICAL INTERBODY DEVICE
- Applicant
- Medicrea
- Decision
- Substantially Equivalent
- Date received
- 2010-02-18
- Decision date
- 2010-03-16
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- ODP
- 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 MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B2018 recall (Z-2456-2023) | Medicrea International | 2023-08-24 |