TRIGEN TROCHANTERIC ANTEGRADE NAIL

Rod, Fixation, Intramedullary And Accessories

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Trigen Trochanteric Antegrade Nail.

Pre-market Notification Details

• Device ID: K040462
• 510k Number: K040462
• Device Name: TRIGEN TROCHANTERIC ANTEGRADE NAIL
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Kim Kelly
• Correspondent: Kim Kelly; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-02-23
• Decision Date: 2004-03-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03596010500892	K040462	000
03596010501295	K040462	000
03596010501301	K040462	000
03596010501318	K040462	000
03596010501325	K040462	000
03596010500786	K040462	000
03596010500793	K040462	000
03596010500809	K040462	000
03596010500816	K040462	000
03596010500823	K040462	000
03596010500830	K040462	000
03596010500847	K040462	000
03596010500854	K040462	000
03596010500861	K040462	000
03596010500878	K040462	000
03596010500885	K040462	000
03596010501288	K040462	000
03596010501271	K040462	000
03596010500908	K040462	000
03596010500915	K040462	000
03596010500922	K040462	000
03596010500939	K040462	000
03596010500946	K040462	000
03596010500953	K040462	000
03596010500960	K040462	000
03596010500977	K040462	000
03596010500984	K040462	000
03596010500991	K040462	000
03596010501226	K040462	000
03596010501233	K040462	000
03596010501240	K040462	000
03596010501257	K040462	000
03596010501264	K040462	000
03596010501004	K040462	000
03596010501011	K040462	000
03596010501196	K040462	000
03596010501202	K040462	000
03596010501219	K040462	000
03596010501332	K040462	000
03596010501349	K040462	000
03596010501356	K040462	000
03596010501363	K040462	000
03596010501370	K040462	000
03596010501387	K040462	000
03596010501394	K040462	000
03596010501400	K040462	000
03596010501417	K040462	000
03596010501424	K040462	000
03596010501431	K040462	000
00885556641187	K040462	000
03596010501189	K040462	000
03596010501172	K040462	000
03596010501028	K040462	000
03596010501035	K040462	000
03596010501042	K040462	000
03596010501059	K040462	000
03596010501066	K040462	000
03596010501073	K040462	000
03596010501080	K040462	000
03596010501097	K040462	000
03596010501103	K040462	000
03596010501110	K040462	000
03596010501127	K040462	000
03596010501134	K040462	000
03596010501141	K040462	000
03596010501158	K040462	000
03596010501165	K040462	000
00885556658284	K040462	000