The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Bioloxdelta / Biolox Femoral Heads, 28mm Od, 32mm Od, 36mm Od, Exactech Biolox Option Adapters/femoral Heads.
| Device ID | K103012 |
| 510k Number | K103012 |
| Device Name: | EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Lindy Knisely |
| Correspondent | Lindy Knisely EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-12 |
| Decision Date | 2010-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862155634 | K103012 | 000 |
| 10885862153609 | K103012 | 000 |
| 10885862153616 | K103012 | 000 |
| 10885862153623 | K103012 | 000 |
| 10885862153630 | K103012 | 000 |
| 10885862153647 | K103012 | 000 |
| 10885862155467 | K103012 | 000 |
| 10885862155474 | K103012 | 000 |
| 10885862155481 | K103012 | 000 |
| 10885862155498 | K103012 | 000 |
| 10885862155559 | K103012 | 000 |
| 10885862155566 | K103012 | 000 |
| 10885862155573 | K103012 | 000 |
| 10885862153593 | K103012 | 000 |