Select Shoulder Cocr Humeral Stem Component

Q: What is the product code of K962289?

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) K962289 · Intermedics Orthopedics

Substantially Equivalent

510(k) numberK962289

Submission

Device name: Select Shoulder Cocr Humeral Stem Component
Applicant: Intermedics Orthopedics
Austin, TX, US
Received: June 14, 1996
Decision date: August 29, 1996
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
K970300	Natural-Hip System Porous Stem with Ha/CstiLPH · Traditional	07/03/1997SE
K970498	Natural-Knee II Revision Femoral Spacer LugsJWH · Traditional	04/30/1997SE
K970166	Natural-Hip System Cocr Revision StemLZO · Traditional	04/08/1997SE
K970567	Select Shoulder Curved-Back Pegged All Poly GlenoidsKWT · Traditional	02/27/1997SE
K964357	Natural-Hip System Cocr StemLZO · Traditional	01/27/1997SE
K964350	Modula Options for Severe Bone Loss and TraumaJDI · Traditional	01/16/1997SE
K962190	Patellofemoral Joint ProsthesisKRR · Traditional	10/28/1996SE
K963266	Natural Hip System Porous Stem - Collarless, CollaredLPH · Traditional	10/15/1996SE
K963155	Intermoore Fracture Hip Stem (Modify)LWJ · Traditional	10/01/1996SE
K962315	Select Shoulder Cocr Humeral Stem ComponentKWT · Traditional	09/03/1996SE

Questions and answers

When was Select Shoulder Cocr Humeral Stem Component cleared by the FDA?

Select Shoulder Cocr Humeral Stem Component (K962289) received a 510(k) decision of Substantially Equivalent on August 29, 1996, 76 days after the submission was received.

What is the product code of K962289?

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