Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L

FDA 510(k) K230946 · Trax Surgical

Substantially Equivalent

510(k) numberK230946

Submission

Device name
Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L
Applicant
Trax Surgical
Stoughton, MA, US
Received
April 4, 2023
Decision date
September 15, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HWC – Screw, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

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K261057ActivaScrew™ Cannulated COMHWC · Traditional Bioretec, Ltd.09/04/2026SE
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K262344Large Compression ScrewsHWC · Special TriMed, Inc.08/12/2026SE
K253858GFS - Sterile Screws and Top HatHWC · Special T.A.G. Medical Products Corporation, Ltd.08/05/2026SE
K262075Lapidus Screw KitHWC · Special Relja Innovations, LLC07/22/2026SE
K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemHWC · Traditional Arthrex, Inc.06/25/2026SE
K253108VEOFIX Snap Off ScrewHWC · Traditional Steps Ortho06/05/2026SE
K261154CoLink® & CoLag® Non-Sterile ScrewsHWC · Special In2Bones USA, LLC05/30/2026SE
K261241TriMed Compression ScrewsHWC · Special TriMed, Inc.05/14/2026SE
K254215Arthrex Beaming SystemHWC · Traditional Arthrex, Inc.05/08/2026SE

More from Arthrex, Inc.

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K251750Trax EX AnchorMBI · Traditional 03/12/2026SE
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Questions and answers

When was Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L cleared by the FDA?

Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L (K230946) received a 510(k) decision of Substantially Equivalent on September 15, 2023, 164 days after the submission was received.

What is the product code of K230946?

The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.