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FDA 510(k)

ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM

K-Number: K970462 · 1997-04-03

ApplicantAcromed Corp.
Decision Date1997-04-03
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acromed Corp.. It received FDA 510(k) clearance on 1997-04-03 under 510(k) number K970462. 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 ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM?

ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-03. The listed applicant is Acromed Corp.. The 510(k) number is K970462.

When did ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM receive FDA 510(k) clearance?

ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM received FDA 510(k) clearance on 1997-04-03, under 510(k) number K970462.

Who is the listed applicant for ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM?

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

What is the FDA product code for ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM?

The FDA product code for ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM is KWQ.

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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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