The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Acumatch P-series Porous Press-fit Femoral Component.
| Device ID | K030236 |
| 510k Number | K030236 |
| Device Name: | ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-23 |
| Decision Date | 2003-02-20 |
| Summary: | summary |