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FDA 510(k)

POROCOAT SCHATZKER II ACETABULUM

K-Number: K852193 · 1985-07-30

ApplicantDepuy, Inc.
Decision Date1985-07-30
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent for Some Indications

Device Summary

POROCOAT SCHATZKER II ACETABULUM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1985-07-30 under 510(k) number K852193. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the POROCOAT SCHATZKER II ACETABULUM?

POROCOAT SCHATZKER II ACETABULUM is a medical device that received FDA 510(k) clearance on 1985-07-30. The listed applicant is Depuy, Inc.. The 510(k) number is K852193.

When did POROCOAT SCHATZKER II ACETABULUM receive FDA 510(k) clearance?

POROCOAT SCHATZKER II ACETABULUM received FDA 510(k) clearance on 1985-07-30, under 510(k) number K852193.

Who is the listed applicant for POROCOAT SCHATZKER II ACETABULUM?

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 POROCOAT SCHATZKER II ACETABULUM?

The FDA product code for POROCOAT SCHATZKER II ACETABULUM is DXQ.

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Other records listing Depuy, Inc. as applicant

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Related Devices (Code: DXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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