The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Howmedica Osteonics Modular Rotating Hinge Knee With Offset Adapters.
| Device ID | K060360 |
| 510k Number | K060360 |
| Device Name: | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Francisco Haro |
| Correspondent | Francisco Haro HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327050271 | K060360 | 000 |
| 07613327050264 | K060360 | 000 |
| 07613327050257 | K060360 | 000 |
| 07613327050042 | K060360 | 000 |