ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
FDA 510(k) clearance K121640 · decided 2012-12-05
Clearance details
- K-number
- K121640
- Device name
- ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
- Applicant
- Materialise NV
- Decision
- Substantially Equivalent
- Date received
- 2012-06-04
- Decision date
- 2012-12-05
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Leuven, BE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to recall (Z-0418-2015) | Materialise USA LLC | 2014-11-21 |