Select Shoulder Cocr Humeral Stem Component

Q: What is the product code of K962315?

The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.

FDA 510(k) K962315 · Intermedics Orthopedics

Substantially Equivalent

510(k) numberK962315

Submission

Device name: Select Shoulder Cocr Humeral Stem Component
Applicant: Intermedics Orthopedics
Austin, TX, US
Received: June 17, 1996
Decision date: September 3, 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: KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3650
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code KWT

510(k)	Device	Applicant	Decision
K262173	N22 Offset Humeral HeadKWT · Traditional	Shoulder Innovations, Inc.	09/08/2026SE
K250713	Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional	Exactech, Inc.	12/01/2025SE
K251686	Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT · Traditional	Tornier, Inc.	10/30/2025SE
K241944	AGILON® XO Shoulder Replacement SystemKWT · Traditional	Implantcast GmbH	03/10/2025SE
K241817	InSet Total Shoulder SystemKWT · Traditional	Shoulder Innovations, Inc.	02/11/2025SE
K231657	AGILON® XO Shoulder Replacement SystemKWT · Traditional	Implantcast GmbH	02/16/2024SE
K223631	Comprehensive Segmental Revision System(SRS)KWT · Traditional	Biomet Orthopedics	07/12/2023SE
K222482	AGILON XO Shoulder SystemKWT · Traditional	Implantcast GmbH	09/28/2022SE
K210899	LINK Embrace Shoulder System- Anatomical ConfigurationKWT · Traditional	Waldemar Link GmbH & Co. KG	06/21/2021SE
K191698	TiN Coated Humeral HeadKWT · Traditional	Fx Shoulder USA, Inc.	07/16/2020SE

More from Fx Shoulder USA, 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
K962289	Select Shoulder Cocr Humeral Stem ComponentHSD · Traditional	08/29/1996SE

Questions and answers

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

Select Shoulder Cocr Humeral Stem Component (K962315) received a 510(k) decision of Substantially Equivalent on September 3, 1996, 78 days after the submission was received.

What is the product code of K962315?

The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.