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FDA 510(k)

SPINE FRONTIER INDUS ACP SYSTEM

K-Number: K121060 · 2012-07-03

ApplicantSpinefrontier, Inc.
Decision Date2012-07-03
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINE FRONTIER INDUS ACP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinefrontier, Inc.. It received FDA 510(k) clearance on 2012-07-03 under 510(k) number K121060. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINE FRONTIER INDUS ACP SYSTEM?

SPINE FRONTIER INDUS ACP SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-03. The listed applicant is Spinefrontier, Inc.. The 510(k) number is K121060.

When did SPINE FRONTIER INDUS ACP SYSTEM receive FDA 510(k) clearance?

SPINE FRONTIER INDUS ACP SYSTEM received FDA 510(k) clearance on 2012-07-03, under 510(k) number K121060.

Who is the listed applicant for SPINE FRONTIER INDUS ACP SYSTEM?

The FDA 510(k) record lists Spinefrontier, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINE FRONTIER INDUS ACP SYSTEM?

The FDA product code for SPINE FRONTIER INDUS ACP SYSTEM is KWQ.

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Other records listing Spinefrontier, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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