The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Abc Total Elbow Prothesis.
| Device ID | K972691 |
| 510k Number | K972691 |
| Device Name: | ABC TOTAL ELBOW PROTHESIS |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Karl Schwartz |
| Correspondent | Karl Schwartz BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDB |
| CFR Regulation Number | 888.3160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-17 |
| Decision Date | 1997-10-15 |
| Summary: | summary |