The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Porous Coat Total Hip Prost Fem Stem Comp.
| Device ID | K901297 |
| 510k Number | K901297 |
| Device Name: | EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Contact | William Petty |
| Correspondent | William Petty EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-20 |
| Decision Date | 1990-05-02 |