The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Modulus Compatible Stability (mcs)-ha Total Hip System.
| Device ID | K990197 |
| 510k Number | K990197 |
| Device Name: | MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| 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 | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-20 |
| Decision Date | 1999-02-04 |
| Summary: | summary |