The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Novation Element Femoral Stem, 12/14 Collarless Standard/high Offset Ha Coated Press-fit, Sz 8-12.
| Device ID | K113320 |
| 510k Number | K113320 |
| Device Name: | NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Vladislava Zaitseva |
| Correspondent | Vladislava Zaitseva 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 | 2011-11-10 |
| Decision Date | 2012-03-16 |
| Summary: | summary |