The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for New Bio-moore Endo Head, Taper Adapter.
| Device ID | K002106 |
| 510k Number | K002106 |
| Device Name: | NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-12 |
| Decision Date | 2000-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304228382 | K002106 | 000 |
| 00880304228375 | K002106 | 000 |
| 00880304228351 | K002106 | 000 |
| 00880304228344 | K002106 | 000 |
| 00880304228337 | K002106 | 000 |