The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedicca Modular Proximal Humerus Replacement System.
| Device ID | K954559 |
| 510k Number | K954559 |
| Device Name: | HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| 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 | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1996-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327049060 | K954559 | 000 |
| 07613327048681 | K954559 | 000 |
| 07613327048940 | K954559 | 000 |
| 07613327048957 | K954559 | 000 |
| 07613327048964 | K954559 | 000 |
| 07613327048971 | K954559 | 000 |
| 07613327048988 | K954559 | 000 |
| 07613327048995 | K954559 | 000 |
| 07613327049008 | K954559 | 000 |
| 07613327049015 | K954559 | 000 |
| 07613327049022 | K954559 | 000 |
| 07613327049039 | K954559 | 000 |
| 07613327049046 | K954559 | 000 |
| 07613327048667 | K954559 | 000 |