The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Novation Femoral Stem, Tapered 12/14 , Standard/extended Offset, Plasma Coated, Press-fit, Size 19/20.
| Device ID | K102487 |
| 510k Number | K102487 |
| Device Name: | NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-30 |
| Decision Date | 2010-11-08 |
| Summary: | summary |