The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Novation Lpi Prime Femoral Stem.
| Device ID | K121684 |
| 510k Number | K121684 |
| Device Name: | NOVATION LPI PRIME FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, 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 | LPH |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-07 |
| Decision Date | 2012-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862272621 | K121684 | 000 |
| 10885862240767 | K121684 | 000 |
| 10885862240774 | K121684 | 000 |
| 10885862240781 | K121684 | 000 |
| 10885862268556 | K121684 | 000 |
| 10885862268563 | K121684 | 000 |
| 10885862240743 | K121684 | 000 |
| 10885862240873 | K121684 | 000 |
| 10885862240880 | K121684 | 000 |
| 10885862240903 | K121684 | 000 |
| 10885862240910 | K121684 | 000 |
| 10885862271754 | K121684 | 000 |
| 10885862240750 | K121684 | 000 |