SPINE FRONTIER INDUS ACP 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 Spine Frontier Indus Acp System.

Pre-market Notification Details

• Device ID: K121060
• 510k Number: K121060
• Device Name: SPINE FRONTIER INDUS ACP SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 Beverly, MA 01915
• Contact: Fredy H Varela
• Correspondent: Fredy H Varela; SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 Beverly, MA 01915
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-06
• Decision Date: 2012-07-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00190361035459	K121060	000
00190361001454	K121060	000
00190361001447	K121060	000
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