The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Acumatch P-series Press-fit Plasma, Acumatch P-series Press-fit, Acumatch L-series Press-fit.
| Device ID | K002141 |
| 510k Number | K002141 |
| Device Name: | ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Lisa Simpson |
| Correspondent | Lisa Simpson EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-17 |
| Decision Date | 2000-08-16 |
| Summary: | summary |