The following data is part of a premarket notification filed by Biomecanica Industria E Comerico De Productos Orto with the FDA for Sp2 Femoral Locking Nail, Sp2 Tibial Locking Nail.
| Device ID | K123745 |
| 510k Number | K123745 |
| Device Name: | SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | BIOMECANICA INDUSTRIA E COMERICO DE PRODUCTOS ORTO 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad BIOMECANICA INDUSTRIA E COMERICO DE PRODUCTOS ORTO 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-06 |
| Decision Date | 2013-03-25 |
| Summary: | summary |