The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Bio-modular Shoulder System With Hydroxyapatite (ha) Coated Glenoid Components.
| Device ID | K043100 |
| 510k Number | K043100 |
| Device Name: | BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBF |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-09 |
| Decision Date | 2005-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304443044 | K043100 | 000 |
| 00880304434127 | K043100 | 000 |
| 00880304433496 | K043100 | 000 |