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 | K994207 |
| 510k Number | K994207 |
| Device Name: | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Mary-catherine Dillon |
| Correspondent | Mary-catherine Dillon HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-14 |
| Decision Date | 2000-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327050097 | K994207 | 000 |
| 07613327043792 | K994207 | 000 |
| 07613327043808 | K994207 | 000 |
| 07613327043815 | K994207 | 000 |
| 07613327043822 | K994207 | 000 |
| 07613327043839 | K994207 | 000 |
| 07613327043846 | K994207 | 000 |
| 07613327043853 | K994207 | 000 |
| 07613327043860 | K994207 | 000 |
| 07613327043884 | K994207 | 000 |
| 07613327050059 | K994207 | 000 |
| 07613327050066 | K994207 | 000 |
| 07613327050073 | K994207 | 000 |
| 07613327050080 | K994207 | 000 |
| 07613327043785 | K994207 | 000 |