Dvo Extended Articulation Humeral Heads

Q: What is the product code of K073331?

The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.

FDA 510(k) K073331 · Dvo Extremity Solutions, LLC

Substantially Equivalent

510(k) numberK073331

Submission

Device name: Dvo Extended Articulation Humeral Heads
Applicant: Dvo Extremity Solutions, LLC
Warsaw, IN, US
Received: November 27, 2007
Decision date: February 19, 2008
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3690
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code HSD

510(k)	Device	Applicant	Decision
K233260	Univers Revers CA Head and AdapterHSD · Traditional	Arthrex, Inc.	02/12/2024SE
K221232	Univers Revers Humeral Cup ImplantHSD · Special	Arthrex, Inc.	05/19/2022SE
K191433	AGILON® XO Shoulder Replacement SystemHSD · Traditional	Implantcast GmbH	11/12/2020SE
K193122	Biocore9 Humeral Resurfacing SystemHSD · Traditional	Biocore9, LLC	05/15/2020SE
K173964	OVOMotion Shoulder Arthroplasty SystemHSD · Traditional	Arthrosurface, Inc.	04/18/2018SE
K161782	Arthrex Univers Revers Shoulder Prosthesis SystemHSD · Traditional	Arthrex, Inc.	11/21/2016SE
K161620	Anatomical Shoulder Domelock Dome centricHSD · Traditional	Zimmer GmbH	11/01/2016SE
K151527	Arthrex Univers Revers CA Heads and AdaptersHSD · Traditional	Arthrex, Inc.	04/19/2016SE
K142942	HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemHSD · Special	Arthrosurface, Inc.	12/19/2014SE
K131298	Exactech Equinoxe Resurfacing Humeral Head SystemHSD · Traditional	Exactech, Inc.	11/26/2013SE

More from Exactech, Inc.

510(k)	Device	Decision
K060988	Total and Hemi Shoulder SystemKWS · Traditional	12/06/2006SE
K052754	Wrist Fusion PlateLXT · Traditional	10/27/2005SE
K052150	Volar Plate SystemHRS · Abbreviated	09/08/2005SE

Questions and answers

When was Dvo Extended Articulation Humeral Heads cleared by the FDA?

Dvo Extended Articulation Humeral Heads (K073331) received a 510(k) decision of Substantially Equivalent on February 19, 2008, 84 days after the submission was received.

What is the product code of K073331?

The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.