RELIANCE LUMBAR IBF SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

Reliance Medical Systems, LLC

The following data is part of a premarket notification filed by Reliance Medical Systems, Llc with the FDA for Reliance Lumbar Ibf System.

Pre-market Notification Details

• Device ID: K113540
• 510k Number: K113540
• Device Name: RELIANCE LUMBAR IBF SYSTEM
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Reliance Medical Systems, LLC 545 SOUTH 500 WEST SUITE 100 Bountiful, UT 84010
• Contact: Bret M Berry
• Correspondent: Bret M Berry; Reliance Medical Systems, LLC 545 SOUTH 500 WEST SUITE 100 Bountiful, UT 84010
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-11-30
• Decision Date: 2012-03-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842566100509	K113540	000
00842566100660	K113540	000
00842566100677	K113540	000
00842566100684	K113540	000
00842566100691	K113540	000
00842566100707	K113540	000
00842566100714	K113540	000
00842566100721	K113540	000
00842566100738	K113540	000
00842566100745	K113540	000
00842566100752	K113540	000
00842566100769	K113540	000
00842566100776	K113540	000
00842566100653	K113540	000
00842566100646	K113540	000
00842566100639	K113540	000
00842566100516	K113540	000
00842566100523	K113540	000
00842566100530	K113540	000
00842566100547	K113540	000
00842566100554	K113540	000
00842566100561	K113540	000
00842566100578	K113540	000
00842566100585	K113540	000
00842566100592	K113540	000
00842566100608	K113540	000
00842566100615	K113540	000
00842566100622	K113540	000
00842566100783	K113540	000
00842566100790	K113540	000
00842566101278	K113540	000
00842566101285	K113540	000
00842566101292	K113540	000
00842566101308	K113540	000
00842566101315	K113540	000
00842566101322	K113540	000
00842566101339	K113540	000
00842566101346	K113540	000
00842566101353	K113540	000
00842566101360	K113540	000
00842566101377	K113540	000
00842566101384	K113540	000
00842566101261	K113540	000
00842566101254	K113540	000
00842566101247	K113540	000
00842566100806	K113540	000
00842566100813	K113540	000
00842566100820	K113540	000
00842566100837	K113540	000
00842566100844	K113540	000
00842566100851	K113540	000
00842566100868	K113540	000
00842566100875	K113540	000
00842566101209	K113540	000
00842566101216	K113540	000
00842566101223	K113540	000
00842566101230	K113540	000
00842566101391	K113540	000