The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Novation Element Press-fit Femoral Stems.
| Device ID | K080980 |
| 510k Number | K080980 |
| Device Name: | EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Xavier Sarabia |
| Correspondent | Xavier Sarabia 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 | 2008-04-07 |
| Decision Date | 2008-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862204172 | K080980 | 000 |
| 10885862249289 | K080980 | 000 |
| 10885862249272 | K080980 | 000 |
| 10885862249265 | K080980 | 000 |
| 10885862249258 | K080980 | 000 |
| 10885862035639 | K080980 | 000 |
| 10885862035622 | K080980 | 000 |
| 10885862035615 | K080980 | 000 |
| 10885862035608 | K080980 | 000 |
| 10885862035592 | K080980 | 000 |
| 10885862035585 | K080980 | 000 |
| 10885862035578 | K080980 | 000 |
| 10885862035561 | K080980 | 000 |
| 10885862035554 | K080980 | 000 |
| 10885862035547 | K080980 | 000 |
| 10885862035530 | K080980 | 000 |
| 10885862249296 | K080980 | 000 |
| 10885862249302 | K080980 | 000 |
| 10885862036025 | K080980 | 000 |
| 10885862036018 | K080980 | 000 |
| 10885862036001 | K080980 | 000 |
| 10885862035998 | K080980 | 000 |
| 10885862035981 | K080980 | 000 |
| 10885862035967 | K080980 | 000 |
| 10885862035523 | K080980 | 000 |
| 10885862035516 | K080980 | 000 |
| 10885862280633 | K080980 | 000 |
| 10885862280626 | K080980 | 000 |
| 10885862249357 | K080980 | 000 |
| 10885862249340 | K080980 | 000 |
| 10885862249333 | K080980 | 000 |
| 10885862249326 | K080980 | 000 |
| 10885862249319 | K080980 | 000 |
| 10885862628985 | K080980 | 000 |