The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Discovery Elbow - X-small.
| Device ID | K090473 |
| 510k Number | K090473 |
| Device Name: | DISCOVERY ELBOW - X-SMALL |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-24 |
| Decision Date | 2009-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446254362 | K090473 | 000 |
| 00190446254355 | K090473 | 000 |
| 00190446254348 | K090473 | 000 |
| 00190446254096 | K090473 | 000 |