The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Acumatch Integrated Hip System M-series Femoral Stem Component.
| Device ID | K993736 |
| 510k Number | K993736 |
| Device Name: | EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-04 |
| Decision Date | 2000-01-20 |
| Summary: | summary |