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FDA 510(k)

ARCHIMED REMEDY CERVICAL PLATE

K-Number: K100215 · 2010-04-07

ApplicantArchimed, Inc.
Decision Date2010-04-07
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARCHIMED REMEDY CERVICAL PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Archimed, Inc.. It received FDA 510(k) clearance on 2010-04-07 under 510(k) number K100215. 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 ARCHIMED REMEDY CERVICAL PLATE?

ARCHIMED REMEDY CERVICAL PLATE is a medical device that received FDA 510(k) clearance on 2010-04-07. The listed applicant is Archimed, Inc.. The 510(k) number is K100215.

When did ARCHIMED REMEDY CERVICAL PLATE receive FDA 510(k) clearance?

ARCHIMED REMEDY CERVICAL PLATE received FDA 510(k) clearance on 2010-04-07, under 510(k) number K100215.

Who is the listed applicant for ARCHIMED REMEDY CERVICAL PLATE?

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

What is the FDA product code for ARCHIMED REMEDY CERVICAL PLATE?

The FDA product code for ARCHIMED REMEDY CERVICAL PLATE 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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