The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Plr Splined Revision Stem.
| Device ID | K994184 |
| 510k Number | K994184 |
| Device Name: | PLR SPLINED REVISION STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-10 |
| Decision Date | 2000-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304208346 | K994184 | 000 |
| 00880304208254 | K994184 | 000 |
| 00880304208261 | K994184 | 000 |
| 00880304208278 | K994184 | 000 |
| 00880304208285 | K994184 | 000 |
| 00880304208292 | K994184 | 000 |
| 00880304208308 | K994184 | 000 |
| 00880304208315 | K994184 | 000 |
| 00880304208322 | K994184 | 000 |
| 00880304208339 | K994184 | 000 |
| 00880304208247 | K994184 | 000 |