The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Healey Revision Component System.
| Device ID | K921139 |
| 510k Number | K921139 |
| Device Name: | HEALEY REVISION COMPONENT SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Dutch Harrison |
| Correspondent | Dutch Harrison BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-10 |
| Decision Date | 1992-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304201132 | K921139 | 000 |
| 00880304201170 | K921139 | 000 |
| 00880304201194 | K921139 | 000 |
| 00880304201217 | K921139 | 000 |
| 00880304201231 | K921139 | 000 |
| 00880304201248 | K921139 | 000 |
| 00880304201255 | K921139 | 000 |
| 00880304201262 | K921139 | 000 |
| 00880304201279 | K921139 | 000 |
| 00880304201286 | K921139 | 000 |
| 00880304201293 | K921139 | 000 |
| 00880304201156 | K921139 | 000 |