The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Duration Stabilized Uhmwpe Knee Comp., Wear Claims.
| Device ID | K972864 |
| 510k Number | K972864 |
| Device Name: | DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Frank Maas |
| Correspondent | Frank Maas HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-04 |
| Decision Date | 1997-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327047738 | K972864 | 000 |
| 07613327047660 | K972864 | 000 |
| 07613327047448 | K972864 | 000 |