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FDA 510(k)

LEIBINGER IMF SCREW

K-Number: K963030 · 1997-04-11

ApplicantHowmedica Leibinger, Inc.
Decision Date1997-04-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEIBINGER IMF SCREW 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 1997-04-11 under 510(k) number K963030. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEIBINGER IMF SCREW?

LEIBINGER IMF SCREW is a medical device that received FDA 510(k) clearance on 1997-04-11. The listed applicant is Howmedica Leibinger, Inc.. The 510(k) number is K963030.

When did LEIBINGER IMF SCREW receive FDA 510(k) clearance?

LEIBINGER IMF SCREW received FDA 510(k) clearance on 1997-04-11, under 510(k) number K963030.

Who is the listed applicant for LEIBINGER IMF SCREW?

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 IMF SCREW?

The FDA product code for LEIBINGER IMF SCREW is DZE.

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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 PLATEK963741LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS

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Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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