The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Howmedica Osteonics Modular Rotating Hinge Knee.
| Device ID | K002552 |
| 510k Number | K002552 |
| Device Name: | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | Jennifer A Daudelin |
| Correspondent | Jennifer A Daudelin HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-17 |
| Decision Date | 2000-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327101089 | K002552 | 000 |
| 07613327045277 | K002552 | 000 |
| 07613327045260 | K002552 | 000 |
| 07613327045253 | K002552 | 000 |
| 07613327045246 | K002552 | 000 |
| 07613327045215 | K002552 | 000 |
| 07613327045208 | K002552 | 000 |
| 07613327045192 | K002552 | 000 |
| 07613327045185 | K002552 | 000 |
| 07613327045178 | K002552 | 000 |
| 07613327045161 | K002552 | 000 |
| 07613327045154 | K002552 | 000 |
| 07613327045147 | K002552 | 000 |
| 07613327045130 | K002552 | 000 |
| 07613327045123 | K002552 | 000 |
| 07613327045109 | K002552 | 000 |
| 07613327045284 | K002552 | 000 |
| 07613327045291 | K002552 | 000 |
| 07613327045307 | K002552 | 000 |
| 07613327101065 | K002552 | 000 |
| 07613327101058 | K002552 | 000 |
| 07613327101041 | K002552 | 000 |
| 07613327048193 | K002552 | 000 |
| 07613327048186 | K002552 | 000 |
| 07613327048179 | K002552 | 000 |
| 07613327048162 | K002552 | 000 |
| 07613327048155 | K002552 | 000 |
| 07613327048148 | K002552 | 000 |
| 07613327047721 | K002552 | 000 |
| 07613327047684 | K002552 | 000 |
| 07613327045376 | K002552 | 000 |
| 07613327045338 | K002552 | 000 |
| 07613327045321 | K002552 | 000 |
| 07613327045314 | K002552 | 000 |
| 07613327043778 | K002552 | 000 |