The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Par 5 Acetabular Component With & Without Hydroxyapatite Coating.
| Device ID | K022094 |
| 510k Number | K022094 |
| Device Name: | PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET, INC. 56 EAST BELL DR. 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 | 2002-06-27 |
| Decision Date | 2002-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304282179 | K022094 | 000 |
| 00880304197350 | K022094 | 000 |
| 00880304197374 | K022094 | 000 |
| 00880304197381 | K022094 | 000 |
| 00880304197404 | K022094 | 000 |
| 00880304282131 | K022094 | 000 |
| 00880304282148 | K022094 | 000 |
| 00880304282155 | K022094 | 000 |
| 00880304282162 | K022094 | 000 |
| 00880304197343 | K022094 | 000 |