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.

Orthopedic › ProstheticShoulder Arthroplasty Implantation System

Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left

Name: Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left
Brand: Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left

2 catalogue numbers from 20-8090-004-01, listed by Orthosoft, Inc., Canada, under Shoulder Arthroplasty Implantation System. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

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 Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left
Listed by	Orthosoft, Inc., Canada
FDA product code	QHE
Device type	Shoulder Arthroplasty Implantation System
Device class	Class 2
Regulation	21 CFR 888.3660
510(k)	K190595
Record published	2019-08-26
Record revised	2023-05-03 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left
Catalogue number	Size	Status
20-8090-004-01		In distribution
20-8090-004-02		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
Arthrex®	Arthrex, Inc.	3
Signature ONE	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

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.