NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM
FDA 510(k) clearance K955778 · decided 1996-03-08
Clearance details
- K-number
- K955778
- Device name
- NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM
- Applicant
- Intermedics Orthopedics
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1995-12-20
- Decision date
- 1996-03-08
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- HRY
- Device class
- 2
- Regulation number
- 888.3530
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Natural-Knee II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS recall (Z-1251-2014) | Zimmer, Inc. | 2014-03-20 |