The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Total Hip System.
| Device ID | K862234 |
| 510k Number | K862234 |
| Device Name: | EXACTECH TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | EXACTECH, INC. 2210 N.W. 28TH ST. Gainesville, FL 32605 |
| Contact | William Petty |
| Correspondent | William Petty EXACTECH, INC. 2210 N.W. 28TH ST. Gainesville, FL 32605 |
| 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 | 1986-06-11 |
| Decision Date | 1986-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862009807 | K862234 | 000 |
| 10885862009630 | K862234 | 000 |
| 10885862009647 | K862234 | 000 |
| 10885862009654 | K862234 | 000 |
| 10885862009661 | K862234 | 000 |
| 10885862009678 | K862234 | 000 |
| 10885862009685 | K862234 | 000 |
| 10885862009722 | K862234 | 000 |
| 10885862009739 | K862234 | 000 |
| 10885862009746 | K862234 | 000 |
| 10885862009753 | K862234 | 000 |
| 10885862009760 | K862234 | 000 |
| 10885862009777 | K862234 | 000 |
| 10885862009784 | K862234 | 000 |
| 10885862009791 | K862234 | 000 |
| 10885862009623 | K862234 | 000 |