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FDA 510(k)

FRONTIER ANTERIOR SCOLIOSIS SYSTEM

K-Number: K012916 · 2001-11-27

ApplicantDepuy Acromed, Inc.
Decision Date2001-11-27
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FRONTIER ANTERIOR SCOLIOSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Acromed, Inc.. It received FDA 510(k) clearance on 2001-11-27 under 510(k) number K012916. 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 FRONTIER ANTERIOR SCOLIOSIS SYSTEM?

FRONTIER ANTERIOR SCOLIOSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2001-11-27. The listed applicant is Depuy Acromed, Inc.. The 510(k) number is K012916.

When did FRONTIER ANTERIOR SCOLIOSIS SYSTEM receive FDA 510(k) clearance?

FRONTIER ANTERIOR SCOLIOSIS SYSTEM received FDA 510(k) clearance on 2001-11-27, under 510(k) number K012916.

Who is the listed applicant for FRONTIER ANTERIOR SCOLIOSIS SYSTEM?

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

What is the FDA product code for FRONTIER ANTERIOR SCOLIOSIS SYSTEM?

The FDA product code for FRONTIER ANTERIOR SCOLIOSIS SYSTEM is KWQ.

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Official Source

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

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