MODIFICATION TO SYNTHES MATRIX SYSTEM
FDA 510(k) clearance K100952 · decided 2010-08-05
Clearance details
- K-number
- K100952
- Device name
- MODIFICATION TO SYNTHES MATRIX SYSTEM
- Applicant
- Synthes Spine
- Decision
- Substantially Equivalent
- Date received
- 2010-04-06
- Decision date
- 2010-08-05
- Days to decision
- 121 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- 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 Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium P recall (Z-0226-2015) | Synthes (USA) Products LLC | 2014-11-26 |
| Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intend recall (Z-3207-2011) | Synthes USA (HQ), Inc. | 2011-09-15 |