Sign Pediatric Fin Nail

FDA 510(k) K122823 · Sign Fracture Care International

Substantially Equivalent

510(k) numberK122823

Submission

Device name
Sign Pediatric Fin Nail
Applicant
Sign Fracture Care International
Richland, WA, US
Received
September 14, 2012
Decision date
April 16, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HSB – Rod, Fixation, Intramedullary And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3020
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code HSB

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K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional Suzhou and Science & Technology Development Corp.06/18/2026SE
K253155Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional Beijing Fule Science & Technology Development…06/17/2026SE
K253046HERA Interlocking Intramedullary Nailing SystemHSB · Traditional ZheJiang Decans Medical Devices Co., Ltd.06/16/2026SE
K260146Fitbone® Transport and Lengthening SystemHSB · Traditional Orthofix Srl05/19/2026SE
K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional Orthofix Srl05/08/2026SE
K261043AUTOBAHN™ Nailing SystemHSB · Special Globus Medical, Inc.04/24/2026SE
K252016Arthrex Humeral NailsHSB · Traditional Arthrex, Inc.03/20/2026SE
K252961Fusion FibFix NailHSB · Traditional Fusion Orthopedics USA, LLC03/18/2026SE

More from Fusion Orthopedics USA, LLC

510(k)DeviceDecision
K163589SIGN IM NailHSB · Traditional 07/20/2017SE
K153759SIGN Compression Screw SystemHWC · Traditional 02/25/2016SE
K152757SIGN Hip Construct (SHC)HSB · Traditional 11/13/2015SE

Questions and answers

When was Sign Pediatric Fin Nail cleared by the FDA?

Sign Pediatric Fin Nail (K122823) received a 510(k) decision of Substantially Equivalent on April 16, 2013, 214 days after the submission was received.

What is the product code of K122823?

The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.