The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Acumatch A-series And Mcs Acetabular Shells And Liners.
| Device ID | K040613 |
| 510k Number | K040613 |
| Device Name: | EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| 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 | MEH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-09 |
| Decision Date | 2004-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862019684 | K040613 | 000 |