The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Modular Replacement System (mrs) Humeral Stem.
| Device ID | K032264 |
| 510k Number | K032264 |
| Device Name: | MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-23 |
| Decision Date | 2003-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327049763 | K032264 | 000 |
| 07613327049756 | K032264 | 000 |
| 07613327049749 | K032264 | 000 |
| 07613327049732 | K032264 | 000 |
| 07613327049725 | K032264 | 000 |
| 07613327049718 | K032264 | 000 |