The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Bipolar Hip Prosthesis.
| Device ID | K905370 |
| 510k Number | K905370 |
| Device Name: | EXACTECH BIPOLAR HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| 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 | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-29 |
| Decision Date | 1991-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862105073 | K905370 | 000 |
| 10885862658623 | K905370 | 000 |
| 10885862658630 | K905370 | 000 |
| 10885862658647 | K905370 | 000 |
| 10885862658654 | K905370 | 000 |
| 10885862658661 | K905370 | 000 |
| 10885862658678 | K905370 | 000 |
| 10885862658685 | K905370 | 000 |
| 10885862658692 | K905370 | 000 |
| 10885862658616 | K905370 | 000 |
| 10885862658609 | K905370 | 000 |
| 10885862658524 | K905370 | 000 |
| 10885862658531 | K905370 | 000 |
| 10885862658548 | K905370 | 000 |
| 10885862658555 | K905370 | 000 |
| 10885862658562 | K905370 | 000 |
| 10885862658579 | K905370 | 000 |
| 10885862658586 | K905370 | 000 |
| 10885862658593 | K905370 | 000 |
| 10885862012760 | K905370 | 000 |
| 10885862012807 | K905370 | 000 |
| 10885862104991 | K905370 | 000 |
| 10885862105004 | K905370 | 000 |
| 10885862105011 | K905370 | 000 |
| 10885862105028 | K905370 | 000 |
| 10885862105035 | K905370 | 000 |
| 10885862105042 | K905370 | 000 |
| 10885862105059 | K905370 | 000 |
| 10885862105066 | K905370 | 000 |
| 10885862104984 | K905370 | 000 |
| 10885862104977 | K905370 | 000 |
| 10885862104892 | K905370 | 000 |
| 10885862104908 | K905370 | 000 |
| 10885862104915 | K905370 | 000 |
| 10885862104922 | K905370 | 000 |
| 10885862104939 | K905370 | 000 |
| 10885862104946 | K905370 | 000 |
| 10885862104953 | K905370 | 000 |
| 10885862104960 | K905370 | 000 |
| 10885862658517 | K905370 | 000 |