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FDA 510(k)

CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM

K-Number: K102689 · 2013-01-17

ApplicantConventus Orthopaedics
Decision Date2013-01-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Conventus Orthopaedics. It received FDA 510(k) clearance on 2013-01-17 under 510(k) number K102689. 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 CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM?

CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-01-17. The listed applicant is Conventus Orthopaedics. The 510(k) number is K102689.

When did CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM receive FDA 510(k) clearance?

CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM received FDA 510(k) clearance on 2013-01-17, under 510(k) number K102689.

Who is the listed applicant for CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM?

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

What is the FDA product code for CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM?

The FDA product code for CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM 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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