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FDA 510(k)

SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM

K-Number: K113405 · 2012-01-11

ApplicantSuspension Orthopaedic Solutions, LLC
Decision Date2012-01-11
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Suspension Orthopaedic Solutions, LLC. It received FDA 510(k) clearance on 2012-01-11 under 510(k) number K113405. 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 SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM?

SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-11. The listed applicant is Suspension Orthopaedic Solutions, LLC. The 510(k) number is K113405.

When did SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM receive FDA 510(k) clearance?

SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM received FDA 510(k) clearance on 2012-01-11, under 510(k) number K113405.

Who is the listed applicant for SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM?

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

What is the FDA product code for SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM?

The FDA product code for SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM is HRS.

Related Clinical Trials

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.

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Other records listing Suspension Orthopaedic Solutions, 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.

K112923SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEMK102143SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEMK102095SUSPENSION CLAVICLE FRACTURE FIXATION 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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