The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Tapered Wedge Femoral Stem.
| Device ID | K140674 |
| 510k Number | K140674 |
| Device Name: | EXACTECH TAPERED WEDGE FEMORAL STEM |
| 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 | Shing Jen Tai, Phd |
| Correspondent | Shing Jen Tai, Phd EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-18 |
| Decision Date | 2014-06-30 |
| Summary: | summary |