The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exatech Mcs Porous Coated Total Hip Femoral Stem.
| Device ID | K921113 |
| 510k Number | K921113 |
| Device Name: | EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Contact | Timothy J Seese |
| Correspondent | Timothy J Seese EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-09 |
| Decision Date | 1993-10-27 |