Sonopet 1Q 3 7cm 1Q Large
FDA 510(k) clearance K223770 · decided 2023-02-16
Clearance details
- K-number
- K223770
- Device name
- Sonopet 1Q 3 7cm 1Q Large
- Applicant
- Stryker Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-12-15
- Decision date
- 2023-02-16
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Portage, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005) | Stryker Corporation | 2016-08-09 |
| SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004) | Stryker Corporation | 2007-09-28 |
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003) | Stryker Corporation | 2002-12-31 |
| TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002) | Stryker Corporation | 1998-06-04 |
| TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001) | Stryker Corporation | 1998-06-04 |
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053) | Stryker Corporation | 1997-06-19 |