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FDA 510(k)

LEIBINGER SELF-DRILLING SCREW

K-Number: K970912 · 1997-10-01

ApplicantHowmedica Leibinger, Inc.
Decision Date1997-10-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEIBINGER SELF-DRILLING 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 1997-10-01 under 510(k) number K970912. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEIBINGER SELF-DRILLING SCREW?

LEIBINGER SELF-DRILLING SCREW is a medical device that received FDA 510(k) clearance on 1997-10-01. The listed applicant is Howmedica Leibinger, Inc.. The 510(k) number is K970912.

When did LEIBINGER SELF-DRILLING SCREW receive FDA 510(k) clearance?

LEIBINGER SELF-DRILLING SCREW received FDA 510(k) clearance on 1997-10-01, under 510(k) number K970912.

Who is the listed applicant for LEIBINGER SELF-DRILLING 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 SELF-DRILLING SCREW?

The FDA product code for LEIBINGER SELF-DRILLING SCREW is HWC. This falls under the Cardiovascular category.

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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.

K972166GUERRERO - BELL DISTRACTORK972154COHEN DISTRACTORK961719EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESESK970911LEE PLATEK963030LEIBINGER IMF SCREWK963741LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS

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Related Devices (Code: HWC)

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

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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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