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 |