Cleared Traditional

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 · Trax Surgical · Orthopedic

Sep 2023

Decision

164d

Days

Class 2

Risk

About This 510(k) Submission

K230946 is an FDA 510(k) clearance for the 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, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Trax Surgical (Stoughton, US). The FDA issued a Cleared decision on September 15, 2023, 164 days after receiving the submission on April 4, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K230946 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 2023
Decision Date	September 15, 2023
Days to Decision	164 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF