The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Kinemax Plus Tibial Spacers.
| Device ID | K964951 |
| 510k Number | K964951 |
| Device Name: | KINEMAX PLUS TIBIAL SPACERS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe 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 | 1996-12-10 |
| Decision Date | 1997-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327050035 | K964951 | 000 |
| 07613327047967 | K964951 | 000 |
| 07613327047950 | K964951 | 000 |
| 07613327047943 | K964951 | 000 |
| 07613327047936 | K964951 | 000 |
| 07613327047929 | K964951 | 000 |
| 07613327047912 | K964951 | 000 |
| 07613327047905 | K964951 | 000 |
| 07613327047899 | K964951 | 000 |
| 07613327047882 | K964951 | 000 |
| 07613327047875 | K964951 | 000 |
| 07613327047868 | K964951 | 000 |
| 07613327047974 | K964951 | 000 |
| 07613327047981 | K964951 | 000 |
| 07613327050028 | K964951 | 000 |
| 07613327048087 | K964951 | 000 |
| 07613327048070 | K964951 | 000 |
| 07613327048063 | K964951 | 000 |
| 07613327048056 | K964951 | 000 |
| 07613327048049 | K964951 | 000 |
| 07613327048032 | K964951 | 000 |
| 07613327048025 | K964951 | 000 |
| 07613327048018 | K964951 | 000 |
| 07613327048001 | K964951 | 000 |
| 07613327047998 | K964951 | 000 |
| 07613327047851 | K964951 | 000 |