The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Modification To: Exactech Ziramic Zirconia 12/14 Femoral Heads.
| Device ID | K060107 |
| 510k Number | K060107 |
| Device Name: | MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 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 | Maritza Elias |
| Correspondent | Maritza Elias 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 | 2006-01-13 |
| Decision Date | 2006-02-06 |
| Summary: | summary |