The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Total Hip Systme: 22mm Femoral Head.
| Device ID | K964262 |
| 510k Number | K964262 |
| Device Name: | EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Contact | Martha Miller |
| Correspondent | Martha Miller EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-25 |
| Decision Date | 1996-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862009296 | K964262 | 000 |
| 10885862009289 | K964262 | 000 |
| 10885862009272 | K964262 | 000 |