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FDA 510(k)

METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM

K-Number: K963700 · 1997-02-12

ApplicantMetagen, LLC
Decision Date1997-02-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Metagen, LLC. It received FDA 510(k) clearance on 1997-02-12 under 510(k) number K963700. 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 METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM?

METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-12. The listed applicant is Metagen, LLC. The 510(k) number is K963700.

When did METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM receive FDA 510(k) clearance?

METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM received FDA 510(k) clearance on 1997-02-12, under 510(k) number K963700.

Who is the listed applicant for METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM?

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

What is the FDA product code for METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM?

The FDA product code for METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM is HRS.

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Other records listing Metagen, LLC 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.

K983976METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEMK980609SEGMENTAL DEFECT REPLACEMENT SYSTEMK980020ACTIVELOCK MODULAR FEMORAL HIP SYSTEMK964003METAGEN ALL POLY ACETABULAR CUP SYSTEM

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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