OGmend® Implant Enhancement System
FDA 510(k) clearance K233223 · decided 2023-10-26
Clearance details
- K-number
- K233223
- Device name
- OGmend® Implant Enhancement System
- Applicant
- Woven Orthopedic Technologies
- Decision
- Substantially Equivalent
- Date received
- 2023-09-28
- Decision date
- 2023-10-26
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- QVI
- Device class
- 2
- Regulation number
- 888.3043
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Manchester, CT, 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 |
|---|---|---|
| Ogmend® Implant Enhancement System (K223075) | Woven Orthopedic Technologies | 2023-02-27 |
Recalls involving this device
No recalls on record reference this clearance.