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 |