The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Novation Crown Cup Constrained Liners And Rings.
| Device ID | K071676 |
| 510k Number | K071676 |
| Device Name: | EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Graham Cuthbert |
| Correspondent | Graham Cuthbert EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-19 |
| Decision Date | 2007-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862038531 | K071676 | 000 |
| 10885862038524 | K071676 | 000 |
| 10885862038517 | K071676 | 000 |
| 10885862038500 | K071676 | 000 |
| 10885862038586 | K071676 | 000 |
| 10885862038579 | K071676 | 000 |
| 10885862038562 | K071676 | 000 |
| 10885862038555 | K071676 | 000 |
| 10885862038548 | K071676 | 000 |