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FDA 510(k)

GARDNER PINS (ADULT & CHILD)

K-Number: K911772 · 1991-08-26

ApplicantCodman & Shurtleff, Inc.
Decision Date1991-08-26
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GARDNER PINS (ADULT & CHILD) is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 1991-08-26 under 510(k) number K911772. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GARDNER PINS (ADULT & CHILD)?

GARDNER PINS (ADULT & CHILD) is a medical device that received FDA 510(k) clearance on 1991-08-26. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K911772.

When did GARDNER PINS (ADULT & CHILD) receive FDA 510(k) clearance?

GARDNER PINS (ADULT & CHILD) received FDA 510(k) clearance on 1991-08-26, under 510(k) number K911772.

Who is the listed applicant for GARDNER PINS (ADULT & CHILD)?

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

What is the FDA product code for GARDNER PINS (ADULT & CHILD)?

The FDA product code for GARDNER PINS (ADULT & CHILD) is HBL.

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Related Devices (Code: HBL)

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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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