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FDA 510(k)

BONE GRAFT WASHER, MODEL 9090114 - 9090118

K-Number: K994122 · 2000-02-18

ApplicantDanek Medical, Inc.
Decision Date2000-02-18
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONE GRAFT WASHER, MODEL 9090114 - 9090118 is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 2000-02-18 under 510(k) number K994122. 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 BONE GRAFT WASHER, MODEL 9090114 - 9090118?

BONE GRAFT WASHER, MODEL 9090114 - 9090118 is a medical device that received FDA 510(k) clearance on 2000-02-18. The listed applicant is Danek Medical, Inc.. The 510(k) number is K994122.

When did BONE GRAFT WASHER, MODEL 9090114 - 9090118 receive FDA 510(k) clearance?

BONE GRAFT WASHER, MODEL 9090114 - 9090118 received FDA 510(k) clearance on 2000-02-18, under 510(k) number K994122.

Who is the listed applicant for BONE GRAFT WASHER, MODEL 9090114 - 9090118?

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

What is the FDA product code for BONE GRAFT WASHER, MODEL 9090114 - 9090118?

The FDA product code for BONE GRAFT WASHER, MODEL 9090114 - 9090118 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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