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FDA 510(k)

HUMERUS LOCKING PLATING SYSTEM

K-Number: K063095 · 2006-12-22

ApplicantNewclip Technics
Decision Date2006-12-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HUMERUS LOCKING PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2006-12-22 under 510(k) number K063095. 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 HUMERUS LOCKING PLATING SYSTEM?

HUMERUS LOCKING PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Newclip Technics. The 510(k) number is K063095.

When did HUMERUS LOCKING PLATING SYSTEM receive FDA 510(k) clearance?

HUMERUS LOCKING PLATING SYSTEM received FDA 510(k) clearance on 2006-12-22, under 510(k) number K063095.

Who is the listed applicant for HUMERUS LOCKING PLATING SYSTEM?

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

What is the FDA product code for HUMERUS LOCKING PLATING SYSTEM?

The FDA product code for HUMERUS LOCKING PLATING SYSTEM is HRS.

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Other records listing Newclip Technics as applicant

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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

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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