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FDA 510(k)

OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME

K-Number: K123832 · 2013-03-20

ApplicantThe Orthopaedic Implant Company (Oic)
Decision Date2013-03-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME is the device name listed in this FDA 510(k) record. The listed applicant is The Orthopaedic Implant Company (Oic). It received FDA 510(k) clearance on 2013-03-20 under 510(k) number K123832. 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 OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME?

OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME is a medical device that received FDA 510(k) clearance on 2013-03-20. The listed applicant is The Orthopaedic Implant Company (Oic). The 510(k) number is K123832.

When did OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME receive FDA 510(k) clearance?

OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME received FDA 510(k) clearance on 2013-03-20, under 510(k) number K123832.

Who is the listed applicant for OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME?

The FDA 510(k) record lists The Orthopaedic Implant Company (Oic) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME?

The FDA product code for OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME is HRS.

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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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