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FDA 510(k)

ULTRACAST WATERLESS SYNTHETIC RESIN CAST

K-Number: K813052 · 1982-02-04

ApplicantZimmer, Inc.
Decision Date1982-02-04
Product CodeITG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ULTRACAST WATERLESS SYNTHETIC RESIN CAST is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K813052. The device is classified under product code ITG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACAST WATERLESS SYNTHETIC RESIN CAST?

ULTRACAST WATERLESS SYNTHETIC RESIN CAST is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Zimmer, Inc.. The 510(k) number is K813052.

When did ULTRACAST WATERLESS SYNTHETIC RESIN CAST receive FDA 510(k) clearance?

ULTRACAST WATERLESS SYNTHETIC RESIN CAST received FDA 510(k) clearance on 1982-02-04, under 510(k) number K813052.

Who is the listed applicant for ULTRACAST WATERLESS SYNTHETIC RESIN CAST?

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

What is the FDA product code for ULTRACAST WATERLESS SYNTHETIC RESIN CAST?

The FDA product code for ULTRACAST WATERLESS SYNTHETIC RESIN CAST is ITG.

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Related Devices (Code: ITG)

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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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