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FDA 510(k)

CROSSLINK AXIAL AND OFFSET PLATES

K-Number: K923242 · 1993-05-19

ApplicantSofamor Danek Mfg., Inc.
Decision Date1993-05-19
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

CROSSLINK AXIAL AND OFFSET PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek Mfg., Inc.. It received FDA 510(k) clearance on 1993-05-19 under 510(k) number K923242. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the CROSSLINK AXIAL AND OFFSET PLATES?

CROSSLINK AXIAL AND OFFSET PLATES is a medical device that received FDA 510(k) clearance on 1993-05-19. The listed applicant is Sofamor Danek Mfg., Inc.. The 510(k) number is K923242.

When did CROSSLINK AXIAL AND OFFSET PLATES receive FDA 510(k) clearance?

CROSSLINK AXIAL AND OFFSET PLATES received FDA 510(k) clearance on 1993-05-19, under 510(k) number K923242.

Who is the listed applicant for CROSSLINK AXIAL AND OFFSET PLATES?

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

What is the FDA product code for CROSSLINK AXIAL AND OFFSET PLATES?

The FDA product code for CROSSLINK AXIAL AND OFFSET PLATES is KWQ.

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Other records listing Sofamor Danek Mfg., 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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