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FDA 510(k)

SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM

K-Number: K102095 · 2010-12-07

ApplicantSuspension Orthopaedic Solutions, LLC
Decision Date2010-12-07
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUSPENSION CLAVICLE FRACTURE FIXATION 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 2010-12-07 under 510(k) number K102095. 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 FIXATION SYSTEM?

SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-07. The listed applicant is Suspension Orthopaedic Solutions, LLC. The 510(k) number is K102095.

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

SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM received FDA 510(k) clearance on 2010-12-07, under 510(k) number K102095.

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

The FDA product code for SUSPENSION CLAVICLE FRACTURE FIXATION 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.

K113405SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEMK112923SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEMK102143SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR 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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