SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
FDA 510(k) clearance K112030 · decided 2012-06-19
Clearance details
- K-number
- K112030
- Device name
- SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
- Applicant
- Synthes USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-07-15
- Decision date
- 2012-06-19
- Days to decision
- 340 days
- Clearance type
- Traditional
- Product code
- KWI
- Device class
- 2
- Regulation number
- 888.3170
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial H recall (Z-1238-2013) | Synthes USA HQ, Inc. | 2013-05-03 |