The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Acumatch M-series Extra-small Metaphyseal Segments.
| Device ID | K011081 |
| 510k Number | K011081 |
| Device Name: | ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-10 |
| Decision Date | 2001-04-24 |