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FDA 510(k)

CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX

K-Number: K100061 · 2010-02-12

ApplicantK2m, Inc.
Decision Date2010-02-12
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2010-02-12 under 510(k) number K100061. 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 CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX?

CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX is a medical device that received FDA 510(k) clearance on 2010-02-12. The listed applicant is K2m, Inc.. The 510(k) number is K100061.

When did CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX receive FDA 510(k) clearance?

CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX received FDA 510(k) clearance on 2010-02-12, under 510(k) number K100061.

Who is the listed applicant for CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX?

The FDA product code for CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX 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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