INDUS ANTERIOR CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

SPINEFRONTIER, INC.

The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Indus Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K093776
• 510k Number: K093776
• Device Name: INDUS ANTERIOR CERVICAL PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: SPINEFRONTIER, INC. 500 CUMMINGS CENTER, STE. 3500 Beverly, MA 01915
• Contact: John Sullivan
• Correspondent: John Sullivan; SPINEFRONTIER, INC. 500 CUMMINGS CENTER, STE. 3500 Beverly, MA 01915
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-12-08
• Decision Date: 2010-03-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00190361001089	K093776	000
00190361001638	K093776	000
00190361001645	K093776	000
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00190361001782	K093776	000
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00190361001546	K093776	000
00190361001553	K093776	000
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00190361001584	K093776	000
00190361001591	K093776	000
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00190361001805	K093776	000
00190361001812	K093776	000
00190361002000	K093776	000
00190361002017	K093776	000
00190361002024	K093776	000
00190361002031	K093776	000
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00190361022107	K093776	000
00190361001997	K093776	000
00190361001980	K093776	000
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00190361001911	K093776	000
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00190361001973	K093776	000
00190361022114	K093776	000