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FDA 510(k)

SPIKED WASHER

K-Number: K914472 · 1991-11-07

ApplicantSynthes (Usa)
Decision Date1991-11-07
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPIKED WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K914472. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIKED WASHER?

SPIKED WASHER is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Synthes (Usa). The 510(k) number is K914472.

When did SPIKED WASHER receive FDA 510(k) clearance?

SPIKED WASHER received FDA 510(k) clearance on 1991-11-07, under 510(k) number K914472.

Who is the listed applicant for SPIKED WASHER?

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

What is the FDA product code for SPIKED WASHER?

The FDA product code for SPIKED WASHER is HTN.

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Other records listing Synthes (Usa) 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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