The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Acumatch 12/14 Press-fit Femoral Stems.
| Device ID | K051335 |
| 510k Number | K051335 |
| Device Name: | ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Maritza Elias |
| Correspondent | Maritza Elias EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | JDI |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-23 |
| Decision Date | 2005-06-21 |
| Summary: | summary |