The following data is part of a premarket notification filed by I.t.s. Gmbh with the FDA for Cfn-cannulated Femur Nail, Ctn-cannulated Tibia Nail, Chn-cannulated Humeral Nail.
| Device ID | K132945 | 
| 510k Number | K132945 | 
| Device Name: | CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL | 
| Classification | Rod, Fixation, Intramedullary And Accessories | 
| Applicant | I.T.S. GMBH 3150 E. 200TH STREET Prior Lake, MN 55372 | 
| Contact | Al Lippincott | 
| Correspondent | Al Lippincott I.T.S. GMBH 3150 E. 200TH STREET Prior Lake, MN 55372 | 
| Product Code | HSB | 
| Subsequent Product Code | HWC | 
| Subsequent Product Code | JDS | 
| Subsequent Product Code | KTT | 
| CFR Regulation Number | 888.3020 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2013-09-19 | 
| Decision Date | 2014-03-07 | 
| Summary: | summary |