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FDA 510(k)

LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS

K-Number: K963740 · 1996-10-28

ApplicantHowmedica Leibinger, Inc.
Decision Date1996-10-28
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS 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 1996-10-28 under 510(k) number K963740. 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 LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS?

LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS is a medical device that received FDA 510(k) clearance on 1996-10-28. The listed applicant is Howmedica Leibinger, Inc.. The 510(k) number is K963740.

When did LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS receive FDA 510(k) clearance?

LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS received FDA 510(k) clearance on 1996-10-28, under 510(k) number K963740.

Who is the listed applicant for LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS?

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 LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS?

The FDA product code for LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS is JEY.

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Other records listing Howmedica Leibinger, Inc. as applicant

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.

K970912LEIBINGER SELF-DRILLING SCREWK972154COHEN DISTRACTORK972166GUERRERO - BELL DISTRACTORK961719EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESESK970911LEE PLATEK963030LEIBINGER IMF SCREW

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Related Devices (Code: JEY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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