CoAptix S System

FDA 510(k) K252699 · University of Utah, Department of Orthopaedics

Substantially Equivalent

510(k) numberK252699

Submission

Device name
CoAptix S System
Applicant
University of Utah, Department of Orthopaedics
Salt Lake City, UT, US
Received
August 27, 2025
Decision date
April 10, 2026
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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K261154CoLink® & CoLag® Non-Sterile ScrewsHWC · Special In2Bones USA, LLC05/30/2026SE
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Questions and answers

When was CoAptix S System cleared by the FDA?

CoAptix S System (K252699) received a 510(k) decision of Substantially Equivalent on April 10, 2026, 226 days after the submission was received.

What is the product code of K252699?

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