The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Acumatch L-series Cemented Femoral Stem, Model Size 1.
| Device ID | K011218 |
| 510k Number | K011218 |
| Device Name: | ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Gary J Miller |
| Correspondent | Gary J Miller EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-20 |
| Decision Date | 2001-05-16 |