SUBTALAR PEG IMPLANT
FDA 510(k) clearance K033046 · decided 2003-12-23
Clearance details
- K-number
- K033046
- Device name
- SUBTALAR PEG IMPLANT
- Applicant
- Nexa Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-29
- Decision date
- 2003-12-23
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- MJW
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LUNDEEN SUBTALAR PEG IMPLANT (K922292) | Sgarlato Laboratories, Inc. | 1992-10-23 |
Recalls involving this device
No recalls on record reference this clearance.