Suspension Acromioclavicular (Ac) Repair System

FDA 510(k) K102143 · Suspension Orthopaedic Solutions, LLC

Substantially Equivalent

510(k) numberK102143

Submission

Device name
Suspension Acromioclavicular (Ac) Repair System
Applicant
Suspension Orthopaedic Solutions, LLC
Shelton, CT, US
Received
July 30, 2010
Decision date
December 8, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JDR – Staple, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K243742Arthrex DynaNite Nitinol StaplesJDR · Traditional Arthrex, Inc.01/31/2025SE
K243658TMC Compression Implant SystemJDR · Special Treace Medical Concepts12/26/2024SE
K242415TMC Compression Implant SystemJDR · Special Treace Medical Concepts09/06/2024SE
K240212COGNiTiON™ Staple SystemJDR · Special Ortho Solutions UK , Ltd.02/23/2024SE
K232990A’TOMIC™ Nitinol Fixation SystemJDR · Traditional Rmr Ortho, LLC01/12/2024SE
K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional Novastep12/04/2023SE

More from Novastep

510(k)DeviceDecision
K113405Suspension Clavicle Fracture Repair SystemHRS · Special 01/11/2012SE
K112923Suspension Clavicle Fracture Fixation SystemHRS · Traditional 12/27/2011SE
K102095Suspension Clavicle Fracture Fixation SystemHRS · Traditional 12/07/2010SE

Questions and answers

When was Suspension Acromioclavicular (Ac) Repair System cleared by the FDA?

Suspension Acromioclavicular (Ac) Repair System (K102143) received a 510(k) decision of Substantially Equivalent on December 8, 2010, 131 days after the submission was received.

What is the product code of K102143?

The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.