Volar Plate System

Q: When was Volar Plate System cleared by the FDA?

Volar Plate System (K052150) received a 510(k) decision of Substantially Equivalent on September 8, 2005, 31 days after the submission was received.

Q: What is the product code of K052150?

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

FDA 510(k) K052150 · Dvo Extremity Solutions, LLC

Substantially Equivalent

510(k) numberK052150

Submission

Device name: Volar Plate System
Applicant: Dvo Extremity Solutions, LLC
Derby, CT, US
Received: August 8, 2005
Decision date: September 8, 2005
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 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

Other 510(k)s with product code HRS

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K261647	Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional	Pace Surgical	09/03/2026SE
K261830	FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional	Ortler Global Tibbi Gerecler Anonim Sirketi	08/28/2026SE
K262537	Versalock Sterile Plating SystemHRS · Special	GM Dos Reis Industria e Comercio Ltda.	08/19/2026SE
K260277	Mikron Trauma Bone Plate& Screw SystemHRS · Traditional	Mikron Makina San. ve Tic. Ltd. Sti.	08/13/2026SE
K261511	Xpert AnkleHRS · Traditional	Newclip Technics	07/28/2026SE
K261406	Versalock Proximal Tibial Plating SystemHRS · Traditional	GM Dos Reis Industria e Comercio Ltda.	07/21/2026SE
K262032	TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special	TriMed, Inc.	07/16/2026SE
K261191	Alians Elbow SHRS · Traditional	Newclip Technics	07/08/2026SE
K261054	RibPlate SystemHRS · Traditional	Stryker Leibinger GmbH & Co KG	07/01/2026SE
K261351	SALGINA 2.5mm Distal Radius SystemHRS · Traditional	Bonebridge AG	06/26/2026SE

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510(k)	Device	Decision
K073331	Dvo Extended Articulation Humeral HeadsHSD · Traditional	02/19/2008SE
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K052754	Wrist Fusion PlateLXT · Traditional	10/27/2005SE

Questions and answers

When was Volar Plate System cleared by the FDA?

Volar Plate System (K052150) received a 510(k) decision of Substantially Equivalent on September 8, 2005, 31 days after the submission was received.

What is the product code of K052150?

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