The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Pca Mtk Ii Total Knee System.
| Device ID | K910235 |
| 510k Number | K910235 |
| Device Name: | PCA MTK II TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Mary C Spicer |
| Correspondent | Mary C Spicer HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-18 |
| Decision Date | 1991-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327101904 | K910235 | 000 |
| 07613327101867 | K910235 | 000 |