CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL

Rod, Fixation, Intramedullary And Accessories

I.T.S. GMBH

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.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09120047302163	K132945	000
09120047301449	K132945	000
09120047301432	K132945	000
09120047301425	K132945	000
09120047301418	K132945	000
09120047301395	K132945	000
09120047301388	K132945	000
09120047301371	K132945	000
09120047301364	K132945	000
09120047301319	K132945	000
09120047301289	K132945	000
09120047301272	K132945	000
09120047301456	K132945	000
09120047301692	K132945	000
09120047302156	K132945	000
09120047302118	K132945	000
09120047301968	K132945	000
09120047301845	K132945	000
09120047301838	K132945	000
09120047301821	K132945	000
09120047301807	K132945	000
09120047301760	K132945	000
09120047301746	K132945	000
09120047301739	K132945	000
09120047301722	K132945	000
09120047301241	K132945	000
09120034301902	K132945	000
09120034301872	K132945	000
09120047302804	K132945	000
09120047302798	K132945	000
09120034301919	K132945	000
09120034301896	K132945	000
09120034301889	K132945	000
09120034301834	K132945	000
09120034301803	K132945	000
09120034301797	K132945	000
09120034301780	K132945	000
09120034301773	K132945	000
09120034301766	K132945	000
09120047302828	K132945	000
09120047302842	K132945	000
09120034301865	K132945	000
09120034301858	K132945	000
09120034301841	K132945	000
09120034301827	K132945	000
09120034301810	K132945	000
09120047302965	K132945	000
09120047302934	K132945	000
09120047302927	K132945	000
09120047302910	K132945	000
09120047302873	K132945	000
09120047302859	K132945	000
09120034301759	K132945	000
09120047302194	K132945	000
09120047304549	K132945	000
09120047304013	K132945	000
09120047303429	K132945	000
09120047303412	K132945	000
09120047303405	K132945	000
09120047303399	K132945	000
09120047303382	K132945	000
09120047303375	K132945	000
09120047303368	K132945	000
09120047303351	K132945	000
09120047303344	K132945	000
09120047303337	K132945	000
09120047304020	K132945	000
09120047304419	K132945	000
09120047304532	K132945	000
09120047304525	K132945	000
09120047304501	K132945	000
09120047304495	K132945	000
09120047304488	K132945	000
09120047304471	K132945	000
09120047304464	K132945	000
09120047304457	K132945	000
09120047304440	K132945	000
09120047304433	K132945	000
09120047304426	K132945	000
09120047303320	K132945	000
09120047303313	K132945	000
09120047303306	K132945	000
09120047303092	K132945	000
09120047303085	K132945	000
09120047302972	K132945	000
09120047302958	K132945	000
09120047302941	K132945	000
09120047302866	K132945	000
09120047302835	K132945	000
09120047302811	K132945	000
09120047302781	K132945	000
09120047302774	K132945	000
09120047302217	K132945	000
09120047303108	K132945	000
09120047303115	K132945	000
09120047303290	K132945	000
09120047303283	K132945	000
09120047303276	K132945	000
09120047303269	K132945	000
09120047303252	K132945	000
09120047303245	K132945	000
09120047303238	K132945	000
09120047303221	K132945	000
09120047303214	K132945	000
09120047303139	K132945	000
09120047303122	K132945	000
09120047302200	K132945	000