CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM

Fastener, Fixation, Nondegradable, Soft Tissue

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Conmed Linvatec Soft Tissue To Bone System.

Pre-market Notification Details

• Device ID: K091549
• 510k Number: K091549
• Device Name: CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM
• Classification: Fastener, Fixation, Nondegradable, Soft Tissue
• Applicant: LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908
• Contact: John Cusack
• Correspondent: John Cusack; LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908
• Product Code: MBI
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-05-27
• Decision Date: 2009-06-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20845854042660	K091549	000
20845854014117	K091549	000
20845854014124	K091549	000
20845854014230	K091549	000
20845854014247	K091549	000
20845854014254	K091549	000
20845854014285	K091549	000
20845854018948	K091549	000
20845854021764	K091549	000
20845854014100	K091549	000
20845854013998	K091549	000
20845854013462	K091549	000
20845854013530	K091549	000
20845854013554	K091549	000
20845854013714	K091549	000
20845854013844	K091549	000
20845854013851	K091549	000
20845854013974	K091549	000
20845854013981	K091549	000
20845854021788	K091549	000
20845854021795	K091549	000
20845854042585	K091549	000
20845854042592	K091549	000
20845854042608	K091549	000
20845854042615	K091549	000
20845854042622	K091549	000
20845854042639	K091549	000
20845854042646	K091549	000
20845854042653	K091549	000
20845854042578	K091549	000
20845854042561	K091549	000
20845854021801	K091549	000
20845854021818	K091549	000
20845854021825	K091549	000
20845854042516	K091549	000
20845854042523	K091549	000
20845854042530	K091549	000
20845854042547	K091549	000
20845854042554	K091549	000
20845854018467	K091549	000