The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Par 5 Acetabular Component.
| Device ID | K000254 |
| 510k Number | K000254 |
| Device Name: | PAR 5 ACETABULAR COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK 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 | 2000-01-28 |
| Decision Date | 2000-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304197336 | K000254 | 000 |
| 00880304197176 | K000254 | 000 |
| 00880304197183 | K000254 | 000 |
| 00880304197206 | K000254 | 000 |
| 00880304197213 | K000254 | 000 |
| 00880304197220 | K000254 | 000 |
| 00880304197237 | K000254 | 000 |
| 00880304197244 | K000254 | 000 |
| 00880304197251 | K000254 | 000 |
| 00880304197268 | K000254 | 000 |
| 00880304197282 | K000254 | 000 |
| 00880304197312 | K000254 | 000 |
| 00880304197169 | K000254 | 000 |