INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60

Intervertebral Fusion Device With Bone Graft, Lumbar

PINNACLE SPINE GROUP, LLC

The following data is part of a premarket notification filed by Pinnacle Spine Group, Llc with the FDA for Infill 41-tlif Convex Oblique Device, Infill 43-tlif Contour Oblique, Infill 44-tlif Contour Oblique And The Infill 60.

Pre-market Notification Details

• Device ID: K133721
• 510k Number: K133721
• Device Name: INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: PINNACLE SPINE GROUP, LLC 1601 Elm St Ste 1930 Dallas, TX 75201
• Contact: Rebecca K Pine
• Correspondent: Rebecca K Pine; PINNACLE SPINE GROUP, LLC 1601 Elm St Ste 1930 Dallas, TX 75201
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-05
• Decision Date: 2014-03-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00814729024854	K133721	000
00814729025332	K133721	000
00814729025349	K133721	000
00814729025356	K133721	000
00814729025363	K133721	000
00814729025370	K133721	000
00814729025387	K133721	000
00814729025394	K133721	000
00814729025400	K133721	000
00814729025417	K133721	000
00814729025424	K133721	000
00814729025431	K133721	000
00814729025448	K133721	000
00814729025455	K133721	000
00814729025462	K133721	000
00814729025479	K133721	000
00814729025721	K133721	000
00814729025738	K133721	000
00814729025325	K133721	000
00814729025318	K133721	000
00814729025301	K133721	000
00814729024861	K133721	000
00814729024878	K133721	000
00814729024885	K133721	000
00814729024892	K133721	000
00814729024908	K133721	000
00814729024915	K133721	000
00814729024922	K133721	000
00814729024939	K133721	000
00814729024946	K133721	000
00814729024953	K133721	000
00814729024960	K133721	000
00814729024977	K133721	000
00814729024984	K133721	000
00814729024991	K133721	000
00814729025004	K133721	000
00814729025011	K133721	000
00814729025028	K133721	000
00814729025745	K133721	000
00814729025752	K133721	000
00814729025769	K133721	000
00814729025974	K133721	000
00814729025981	K133721	000
00814729025998	K133721	000
00814729026001	K133721	000
00814729026018	K133721	000
00814729026025	K133721	000
00814729026032	K133721	000
00814729026049	K133721	000
00814729026056	K133721	000
00814729026063	K133721	000
00814729026070	K133721	000
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00814729026094	K133721	000
00814729026100	K133721	000
00814729026117	K133721	000
00814729026124	K133721	000
00814729026131	K133721	000
00814729025967	K133721	000
00814729025950	K133721	000
00814729025943	K133721	000
00814729025776	K133721	000
00814729025783	K133721	000
00814729025790	K133721	000
00814729025806	K133721	000
00814729025813	K133721	000
00814729025820	K133721	000
00814729025837	K133721	000
00814729025844	K133721	000
00814729025851	K133721	000
00814729025868	K133721	000
00814729025875	K133721	000
00814729025882	K133721	000
00814729025899	K133721	000
00814729025905	K133721	000
00814729025912	K133721	000
00814729025929	K133721	000
00814729025936	K133721	000
00814729026148	K133721	000