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FDA 510(k)

GUERRERO - BELL DISTRACTOR

K-Number: K972166 · 1997-08-11

ApplicantHowmedica Leibinger, Inc.
Decision Date1997-08-11
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GUERRERO - BELL DISTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Leibinger, Inc.. It received FDA 510(k) clearance on 1997-08-11 under 510(k) number K972166. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUERRERO - BELL DISTRACTOR?

GUERRERO - BELL DISTRACTOR is a medical device that received FDA 510(k) clearance on 1997-08-11. The listed applicant is Howmedica Leibinger, Inc.. The 510(k) number is K972166.

When did GUERRERO - BELL DISTRACTOR receive FDA 510(k) clearance?

GUERRERO - BELL DISTRACTOR received FDA 510(k) clearance on 1997-08-11, under 510(k) number K972166.

Who is the listed applicant for GUERRERO - BELL DISTRACTOR?

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

What is the FDA product code for GUERRERO - BELL DISTRACTOR?

The FDA product code for GUERRERO - BELL DISTRACTOR is JEY.

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Other records listing Howmedica Leibinger, Inc. as applicant

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Related Devices (Code: JEY)

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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