What is FDA product code QHE?

Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

Arthrex® · Shoulder Arthroplasty Implantation System → Orthopedic

Name: Arthrex®
Brand: Arthrex®

1manufacturer

3catalogue numbers in this listing

3510(k) clearances naming this product code

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code QHE
Manufacturer	City	Province	Registered as	Device types
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38

Record

Regulatory record for Arthrex®
Listed by	Arthrex, Inc., United States
FDA product code	QHE
Device type	Shoulder Arthroplasty Implantation System
Device class	Class 2
Regulation	21 CFR 888.3660
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter
Record published	2023-04-24
Record revised	2023-10-04 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Arthrex®
Catalogue number	Size	Status
AR-5410-28		In distribution
AR-5410T-AMGS-M		In distribution
5566VIP		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Smart Space Shoulder	Limacorporate	13
Core Shoulder System	Link BIO Corp	13
Blueprint	Tornier Inc.	5
SurgiCase Planner	Materialise NV	3
Signature ONE Software Package	Orthosoft, Inc.	3
Signature ONE	Orthosoft, Inc.	2
Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left	Orthosoft, Inc.	2
AtlasPlan	Materialise NV	2
Match Point System	Materialise NV	2
Comprehensive® Total Shoulder Guide and Bone Model Right	Orthosoft, Inc.	2
Comprehensive® Reverse Shoulder Mini Guide and Bone Model Left	Orthosoft, Inc.	2
Shoulder Pure Planning	Orthosoft, Inc.	1

Showing 12 of 16. All products under Shoulder Arthroplasty Implantation System

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K241097	2024-10-02
K230904	2023-06-22
K222007	2023-03-08

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Arthrex®