K972774 is an FDA 510(k) clearance for the GAS PLASMA STERILIZATION. This device is classified as a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II - Special Controls, product code JWH).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 5, 1999, 650 days after receiving the submission on July 24, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K972774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1997 |
| Decision Date | May 05, 1999 |
| Days to Decision | 650 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |