The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Taperloc 12/14 Taper Femoral Components.
| Device ID | K043537 |
| 510k Number | K043537 |
| Device Name: | TAPERLOC 12/14 TAPER FEMORAL COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-22 |
| Decision Date | 2005-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304707535 | K043537 | 000 |
| 00880304230699 | K043537 | 000 |
| 00880304011205 | K043537 | 000 |
| 00880304002838 | K043537 | 000 |
| 00880304002609 | K043537 | 000 |
| 00880304598379 | K043537 | 000 |
| 00887868474279 | K043537 | 000 |
| 00887868474262 | K043537 | 000 |
| 00887868474255 | K043537 | 000 |
| 00887868474248 | K043537 | 000 |
| 00887868474231 | K043537 | 000 |
| 00880304230712 | K043537 | 000 |
| 00880304432499 | K043537 | 000 |
| 00880304707528 | K043537 | 000 |
| 00880304707511 | K043537 | 000 |
| 00880304707504 | K043537 | 000 |
| 00880304707498 | K043537 | 000 |
| 00880304707481 | K043537 | 000 |
| 00880304432604 | K043537 | 000 |
| 00880304432536 | K043537 | 000 |
| 00880304432529 | K043537 | 000 |
| 00880304432512 | K043537 | 000 |
| 00880304432505 | K043537 | 000 |
| 00887868474224 | K043537 | 000 |