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FDA 510(k)

SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM

K-Number: K102143 · 2010-12-08

ApplicantSuspension Orthopaedic Solutions, LLC
Decision Date2010-12-08
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUSPENSION ACROMIOCLAVICULAR (AC) 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 2010-12-08 under 510(k) number K102143. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM?

SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-08. The listed applicant is Suspension Orthopaedic Solutions, LLC. The 510(k) number is K102143.

When did SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM receive FDA 510(k) clearance?

SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM received FDA 510(k) clearance on 2010-12-08, under 510(k) number K102143.

Who is the listed applicant for SUSPENSION ACROMIOCLAVICULAR (AC) 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 ACROMIOCLAVICULAR (AC) REPAIR SYSTEM?

The FDA product code for SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM is JDR.

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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 SYSTEMK102095SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM

Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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