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FDA 510(k)

EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES

K-Number: K961719 · 1997-07-17

ApplicantHowmedica Leibinger, Inc.
Decision Date1997-07-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES 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 1997-07-17 under 510(k) number K961719. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES?

EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES is a medical device that received FDA 510(k) clearance on 1997-07-17. The listed applicant is Howmedica Leibinger, Inc.. The 510(k) number is K961719.

When did EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES receive FDA 510(k) clearance?

EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES received FDA 510(k) clearance on 1997-07-17, under 510(k) number K961719.

Who is the listed applicant for EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES?

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 EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES?

The FDA product code for EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES is HRS.

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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 DISTRACTORK970911LEE PLATEK963030LEIBINGER IMF SCREWK963741LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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