The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Kinematic Ii Rotating Hinge Knee.
| Device ID | K992346 |
| 510k Number | K992346 |
| Device Name: | KINEMATIC II ROTATING HINGE KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | LGE |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-13 |
| Decision Date | 1999-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327048698 | K992346 | 000 |
| 07613327048261 | K992346 | 000 |
| 07613327048254 | K992346 | 000 |
| 07613327048247 | K992346 | 000 |
| 07613327048223 | K992346 | 000 |