CAS PSI KNEE SYSTEM
FDA 510(k) clearance K131409 · decided 2013-09-13
Clearance details
- K-number
- K131409
- Device name
- CAS PSI KNEE SYSTEM
- Applicant
- Orthosoft, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-05-15
- Decision date
- 2013-09-13
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Montreal, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer recall (Z-0495-2015) | Zimmer CAS | 2014-12-16 |