NATURAL-KNEE II CONSTRAINED KNEE SYSTEM
FDA 510(k) clearance K973412 · decided 1997-12-08
Clearance details
- K-number
- K973412
- Device name
- NATURAL-KNEE II CONSTRAINED KNEE SYSTEM
- Applicant
- Sulzer Orthopedics, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1997-09-09
- Decision date
- 1997-12-08
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- 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 Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration recall (Z-1948-2015) | Zimmer, Inc. | 2015-07-01 |
| Natural-Knee II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-L recall (Z-1256-2014) | Zimmer, Inc. | 2014-03-20 |