Stabiliz Fixation System - SPL Locking Screw

FDA 510(k) K130731 · Stabiliz Orthopaedics, LLC

Substantially Equivalent

510(k) numberK130731

Submission

Device name
Stabiliz Fixation System - SPL Locking Screw
Applicant
Stabiliz Orthopaedics, LLC
Exton, PA, US
Received
March 18, 2013
Decision date
July 19, 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
HRS – Plate, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special TriMed, Inc.07/16/2026SE
K261191Alians Elbow SHRS · Traditional Newclip Technics07/08/2026SE
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More from Bonebridge AG

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K260112QuikFix External Fixator: Knee-Spanning PackKTT · Traditional 03/23/2026SE
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K120651Stabiliz Fixation SystemHRS · Traditional 11/27/2012SE

Questions and answers

When was Stabiliz Fixation System - SPL Locking Screw cleared by the FDA?

Stabiliz Fixation System - SPL Locking Screw (K130731) received a 510(k) decision of Substantially Equivalent on July 19, 2013, 123 days after the submission was received.

What is the product code of K130731?

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