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FDA 510(k)

SYNATOMIC STANDARD TIBIAL PLATEAU

K-Number: K844355 · 1985-02-07

ApplicantDepuy, Inc.
Decision Date1985-02-07
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNATOMIC STANDARD TIBIAL PLATEAU is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1985-02-07 under 510(k) number K844355. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNATOMIC STANDARD TIBIAL PLATEAU?

SYNATOMIC STANDARD TIBIAL PLATEAU is a medical device that received FDA 510(k) clearance on 1985-02-07. The listed applicant is Depuy, Inc.. The 510(k) number is K844355.

When did SYNATOMIC STANDARD TIBIAL PLATEAU receive FDA 510(k) clearance?

SYNATOMIC STANDARD TIBIAL PLATEAU received FDA 510(k) clearance on 1985-02-07, under 510(k) number K844355.

Who is the listed applicant for SYNATOMIC STANDARD TIBIAL PLATEAU?

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

What is the FDA product code for SYNATOMIC STANDARD TIBIAL PLATEAU?

The FDA product code for SYNATOMIC STANDARD TIBIAL PLATEAU is HSX.

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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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