INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC

Intervertebral Fusion Device With Integrated Fixation, Lumbar

RSB SPINE LLC.

The following data is part of a premarket notification filed by Rsb Spine Llc. with the FDA for Interplate Interbody Fusion Device, Models C, Cgc, L And Lgc.

Pre-market Notification Details

• Device ID: K071922
• 510k Number: K071922
• Device Name: INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: RSB SPINE LLC. 8202 SHERMAN ROAD Chesterland, OH 44026
• Contact: Karen E Warden
• Correspondent: Karen E Warden; RSB SPINE LLC. 8202 SHERMAN ROAD Chesterland, OH 44026
• Product Code: OVD
• Subsequent Product Code: KWQ
• Subsequent Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-07-12
• Decision Date: 2007-09-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817893021384	K071922	000
00817893020684	K071922	000
00817893020660	K071922	000
00817893020653	K071922	000
00817893020646	K071922	000
00817893020639	K071922	000
00817893020615	K071922	000
00817893020608	K071922	000
00817893020592	K071922	000
00817893020707	K071922	000
00817893020714	K071922	000
00817893020721	K071922	000
00817893021377	K071922	000
00817893021360	K071922	000
00817893021353	K071922	000
00817893021346	K071922	000
00817893021339	K071922	000
00817893021322	K071922	000
00817893020745	K071922	000
00817893020738	K071922	000
00817893020585	K071922	000
00817893020578	K071922	000
00817893020349	K071922	000
00817893020332	K071922	000
00817893020325	K071922	000
00817893020318	K071922	000
00817893020301	K071922	000
00817893020295	K071922	000
00817893020288	K071922	000
00817893020271	K071922	000
00817893020356	K071922	000
00817893020363	K071922	000
00817893020370	K071922	000
00817893020554	K071922	000
00817893020448	K071922	000
00817893020431	K071922	000
00817893020424	K071922	000
00817893020417	K071922	000
00817893020400	K071922	000
00817893020394	K071922	000
00817893020387	K071922	000
00817893020264	K071922	000
00817893022084	K071922	000
00817893021926	K071922	000
00817893021919	K071922	000
00817893021902	K071922	000
00817893021896	K071922	000
00817893021889	K071922	000
00817893021872	K071922	000
00817893021865	K071922	000
00817893021841	K071922	000
00817893021933	K071922	000
00817893021940	K071922	000
00817893021995	K071922	000
00817893022077	K071922	000
00817893022060	K071922	000
00817893022053	K071922	000
00817893022046	K071922	000
00817893022039	K071922	000
00817893022022	K071922	000
00817893022015	K071922	000
00817893022008	K071922	000
00817893021605	K071922	000
00817893021599	K071922	000
00817893021476	K071922	000
00817893021469	K071922	000
00817893021452	K071922	000
00817893021445	K071922	000
00817893021438	K071922	000
00817893021421	K071922	000
00817893021414	K071922	000
00817893021407	K071922	000
00817893021483	K071922	000
00817893021490	K071922	000
00817893021506	K071922	000
00817893021582	K071922	000
00817893021575	K071922	000
00817893021568	K071922	000
00817893021551	K071922	000
00817893021544	K071922	000
00817893021537	K071922	000
00817893021520	K071922	000
00817893021513	K071922	000
00817893021391	K071922	000