The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Ziramic Zirconia 12/14 Femoral Heads.
| Device ID | K050398 |
| 510k Number | K050398 |
| Device Name: | 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 | Lisa Simpson |
| Correspondent | Lisa Simpson 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 | 2005-02-16 |
| Decision Date | 2005-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862027931 | K050398 | 000 |
| 10885862027801 | K050398 | 000 |
| 10885862027818 | K050398 | 000 |
| 10885862027825 | K050398 | 000 |
| 10885862027832 | K050398 | 000 |
| 10885862027849 | K050398 | 000 |
| 10885862027856 | K050398 | 000 |
| 10885862027863 | K050398 | 000 |
| 10885862027870 | K050398 | 000 |
| 10885862027887 | K050398 | 000 |
| 10885862027894 | K050398 | 000 |
| 10885862027900 | K050398 | 000 |
| 10885862027917 | K050398 | 000 |
| 10885862027924 | K050398 | 000 |
| 10885862027795 | K050398 | 000 |