The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for M2a Magnum 12/14 Taper Inserts And One-piece Modular Heads.
Device ID | K061423 |
510k Number | K061423 |
Device Name: | M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS |
Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
Contact | Becky Earl |
Correspondent | Becky Earl BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
Product Code | KWA |
CFR Regulation Number | 888.3330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-23 |
Decision Date | 2006-07-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304537392 | K061423 | 000 |
00880304647336 | K061423 | 000 |
00880304647312 | K061423 | 000 |
00880304647299 | K061423 | 000 |
00880304647275 | K061423 | 000 |
00880304647268 | K061423 | 000 |
00880304476936 | K061423 | 000 |
00887868462993 | K061423 | 000 |