The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Porous Titanium Acetabular Shells.
| Device ID | K052996 |
| 510k Number | K052996 |
| Device Name: | POROUS TITANIUM ACETABULAR SHELLS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Allison Koskey |
| Correspondent | Allison Koskey BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MAY |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-25 |
| Decision Date | 2006-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304453807 | K052996 | 000 |
| 00887868342271 | K052996 | 000 |
| 00887868342264 | K052996 | 000 |
| 00887868342257 | K052996 | 000 |
| 00887868342240 | K052996 | 000 |
| 00887868342233 | K052996 | 000 |
| 00887868342226 | K052996 | 000 |
| 00887868342219 | K052996 | 000 |
| 00887868342202 | K052996 | 000 |
| 00887868342196 | K052996 | 000 |
| 00887868342189 | K052996 | 000 |
| 00887868342288 | K052996 | 000 |
| 00880304449244 | K052996 | 000 |
| 00880304449251 | K052996 | 000 |
| 00880304449350 | K052996 | 000 |
| 00880304449343 | K052996 | 000 |
| 00880304449336 | K052996 | 000 |
| 00880304449329 | K052996 | 000 |
| 00880304449312 | K052996 | 000 |
| 00880304449305 | K052996 | 000 |
| 00880304449299 | K052996 | 000 |
| 00880304449282 | K052996 | 000 |
| 00880304449275 | K052996 | 000 |
| 00880304449268 | K052996 | 000 |
| 00887868342172 | K052996 | 000 |