The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Ceramic Femoral Head Component.
| Device ID | K914574 |
| 510k Number | K914574 |
| Device Name: | EXACTECH CERAMIC FEMORAL HEAD COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Contact | Tim Seese |
| Correspondent | Tim Seese EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-15 |
| Decision Date | 1992-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862113214 | K914574 | 000 |
| 10885862113207 | K914574 | 000 |