The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Acumatch A-series & Mcs Constrained Acetabular Liners.
| Device ID | K040601 |
| 510k Number | K040601 |
| Device Name: | EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Gary Miller |
| Correspondent | Gary Miller EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-08 |
| Decision Date | 2004-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862027597 | K040601 | 000 |
| 10885862027580 | K040601 | 000 |
| 10885862027573 | K040601 | 000 |
| 10885862027566 | K040601 | 000 |
| 10885862027559 | K040601 | 000 |
| 10885862027542 | K040601 | 000 |
| 10885862027535 | K040601 | 000 |
| 10885862027528 | K040601 | 000 |