Bicortical Fixation Screw & Washer Nut System

Q: What is the product code of K153638?

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

FDA 510(k) K153638 · First Ray, LLC

Substantially Equivalent

510(k) numberK153638

Submission

Device name: Bicortical Fixation Screw & Washer Nut System
Applicant: First Ray, LLC
Logan, UT, US
Received: December 18, 2015
Decision date: April 19, 2016
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

Other 510(k)s with product code HWC

510(k)	Device	Applicant	Decision
K261057	ActivaScrew Cannulated COMHWC · Traditional	Bioretec, Ltd.	09/04/2026SE
K260106	OsteoCoil GT Active Compression SystemHWC · Traditional	Flower Orthopedics Corporation DBA Conventus…	08/24/2026SE
K262344	Large Compression ScrewsHWC · Special	TriMed, Inc.	08/12/2026SE
K253858	GFS - Sterile Screws and Top HatHWC · Special	T.A.G. Medical Products Corporation, Ltd.	08/05/2026SE
K262075	Lapidus Screw KitHWC · Special	Relja Innovations, LLC	07/22/2026SE
K260809	Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional	Arthrex, Inc.	06/25/2026SE
K253108	VEOFIX Snap Off ScrewHWC · Traditional	Steps Ortho	06/05/2026SE
K261154	CoLink® & CoLag® Non-Sterile ScrewsHWC · Special	In2Bones USA, LLC	05/30/2026SE
K261241	TriMed Compression ScrewsHWC · Special	TriMed, Inc.	05/14/2026SE
K254215	Arthrex Beaming SystemHWC · Traditional	Arthrex, Inc.	05/08/2026SE

More from Arthrex, Inc.

510(k)	Device	Decision
K163440	Stealth Staple SystemJDR · Traditional	02/01/2017SE
K153585	Flip Button Suture AnchorMBI · Traditional	05/05/2016SE
K153622	First Ray Internal Bone Staple SystemJDR · Traditional	04/08/2016SE

Questions and answers

When was Bicortical Fixation Screw & Washer Nut System cleared by the FDA?

Bicortical Fixation Screw & Washer Nut System (K153638) received a 510(k) decision of Substantially Equivalent on April 19, 2016, 123 days after the submission was received.

What is the product code of K153638?

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