The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Zirconia Ceramic Modular Heads.
Device ID | K905687 |
510k Number | K905687 |
Device Name: | ZIRCONIA CERAMIC MODULAR HEADS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
Contact | Patricia M Sandborn |
Correspondent | Patricia M Sandborn BIOMET, INC. 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 | 1990-12-19 |
Decision Date | 1991-04-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304255326 | K905687 | 000 |
00880304255265 | K905687 | 000 |
00880304001480 | K905687 | 000 |