SPIRA Open Matrix ALIF

Intervertebral Fusion Device With Bone Graft, Lumbar

CAMBER SPINE TECHNOLOGIES

The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Spira Open Matrix Alif.

Pre-market Notification Details

• Device ID: K162986
• 510k Number: K162986
• Device Name: SPIRA Open Matrix ALIF
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: CAMBER SPINE TECHNOLOGIES 418 E. Lancaster Avenue Wayne, PA 19087
• Contact: Michael Black
• Correspondent: Justin Eggleton; MCRA,LLC 1050 K Street NW, Suite 1000 Washington, DC 20001
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-10-27
• Decision Date: 2017-06-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B030SPO263208090	K162986	000
B030SPO303808170	K162986	000
B030SPO303808190	K162986	000
B030SPO303815110	K162986	000
B030SPO303815130	K162986	000
B030SPO303815150	K162986	000
B030SPO303815170	K162986	000
B030SPO303815190	K162986	000
B030SPO303820130	K162986	000
B030SPO303820150	K162986	000
B030SPO303820170	K162986	000
B030SPO303820190	K162986	000
B030SPA232608090	K162986	000
B030SPA232608110	K162986	000
B030SPA232608130	K162986	000
B030SPO303808150	K162986	000
B030SPO303808130	K162986	000
B030SPO263208110	K162986	000
B030SPO263208130	K162986	000
B030SPO263208150	K162986	000
B030SPO263208170	K162986	000
B030SPO263215110	K162986	000
B030SPO263215130	K162986	000
B030SPO263215150	K162986	000
B030SPO263215170	K162986	000
B030SPO263220110	K162986	000
B030SPO263220130	K162986	000
B030SPO263220150	K162986	000
B030SPO263220170	K162986	000
B030SPO303808090	K162986	000
B030SPO303808110	K162986	000
B030SPA232608150	K162986	000
B030SPA232615090	K162986	000
B030SPA303808090	K162986	000
B030SPA303808110	K162986	000
B030SPA303808130	K162986	000
B030SPA303808150	K162986	000
B030SPA303808170	K162986	000
B030SPA303808190	K162986	000
B030SPA303815110	K162986	000
B030SPA303815130	K162986	000
B030SPA303815150	K162986	000
B030SPA303815170	K162986	000
B030SPA303815190	K162986	000
B030SPA303820130	K162986	000
B030SPA303820150	K162986	000
B030SPA303820170	K162986	000
B030SPA263220170	K162986	000
B030SPA263220150	K162986	000
B030SPA232615110	K162986	000
B030SPA232615130	K162986	000
B030SPA232615150	K162986	000
B030SPA263208090	K162986	000
B030SPA263208110	K162986	000
B030SPA263208130	K162986	000
B030SPA263208150	K162986	000
B030SPA263208170	K162986	000
B030SPA263215110	K162986	000
B030SPA263215130	K162986	000
B030SPA263215150	K162986	000
B030SPA263215170	K162986	000
B030SPA263220110	K162986	000
B030SPA263220130	K162986	000
B030SPA303820190	K162986	000