The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet Biaxial Total Elbow.
| Device ID | K980428 |
| 510k Number | K980428 |
| Device Name: | BIOMET BIAXIAL TOTAL ELBOW |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Deborah M Matarazzo R.n., B.s.n. |
| Correspondent | Deborah M Matarazzo R.n., B.s.n. BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-04 |
| Decision Date | 1998-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304820913 | K980428 | 000 |