The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Howmedica Osteonics Radial Head Prothesis.
| Device ID | K001385 |
| 510k Number | K001385 |
| Device Name: | HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS |
| Classification | Prosthesis, Elbow, Hemi-, Radial, 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 | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-02 |
| Decision Date | 2000-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327136029 | K001385 | 000 |
| 07613327136012 | K001385 | 000 |
| 07613327136005 | K001385 | 000 |
| 07613327135992 | K001385 | 000 |
| 07613327135985 | K001385 | 000 |