The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for C2 Femoral Stem.
| Device ID | K170473 |
| 510k Number | K170473 |
| Device Name: | C2 Femoral Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Limacorporate S.p.A. via Nazionale 52 Villanova Di San Daniele, IT 33038 |
| Contact | Antonio Soleti |
| Correspondent | Stephen Peoples Peoples & Associates - Stephen J. Peoples, VMD, MS 5010 Lodge Pole Lane Fort Wayne, IN 46814 |
| Product Code | LZO |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-16 |
| Decision Date | 2017-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390071673 | K170473 | 000 |
| 08033390066631 | K170473 | 000 |
| 08033390066648 | K170473 | 000 |
| 08033390066655 | K170473 | 000 |
| 08033390066525 | K170473 | 000 |
| 08033390066532 | K170473 | 000 |
| 08033390066549 | K170473 | 000 |
| 08033390066556 | K170473 | 000 |
| 08033390066594 | K170473 | 000 |
| 08033390071659 | K170473 | 000 |
| 08033390071666 | K170473 | 000 |
| 08033390024938 | K170473 | 000 |
| 08033390066624 | K170473 | 000 |