What is FDA product code OQG?

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.

Cross-Over Acetabular Shell and Liner System · Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented → Orthopedic

Name: Cross-Over Acetabular Shell and Liner System
Brand: Cross-Over Acetabular Shell and Liner System

8manufacturers in China registered for this device type

2catalogue numbers in this listing

1recall

Who Else Makes It

Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OQG
Manufacturer	City	Province	Registered as	Device types
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
APS Materials Suzhou	Suzhou	Jiangsu	Contract manufacturer	18
Lincotek (Wuxi) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	7
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Shenzhen Fox Hunting E-commerce Co., Ltd.	Shenzhen	Guangdong	Exporter	7

Record

Regulatory record for Cross-Over Acetabular Shell and Liner System
Listed by	Globus Medical, Inc., United States
FDA product code	OQG
Device type	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Device class	Class 2
Regulation	21 CFR 888.3358
Establishment	Manufacturer, Exporter
Premarket notification	Exempt
Record published	2015-02-27
Record revised	2020-12-11 (version 3)

Specifications

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

Catalogue Numbers

Catalogue numbers for Cross-Over Acetabular Shell and Liner System
Catalogue number	Size	Status
SC3459-52		In distribution
SC3474-52		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
CS2 Acet. Cup Sys. – VitalitE	Shalby Advanced Technologies, Inc.	169
iTotal® Hip Replacement System	ConforMIS, Inc.	131
CS2 Acet. Cup Sys. – VitalitE	Consensus Orthopedics, Inc.	124
DJO Surgical	Encore Medical, L.P.	99
MobileLink Acetabular Cup System	Waldemar Link GmbH & Co. KG	68
G7	Biomet Orthopedics	54
Vitelene®	Aesculap AG	52
Conformis Hip System	ConforMIS, Inc.	51
Onvoy	Globus Medical, Inc.	48
Ringloc HIP System	Biomet Orthopedics	35
Novosource Total Hip System	Novosource, LLC	33
Prime	Microport Orthopedics Inc.	32

Showing 12 of 100. All products under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2013-01-24	Class II	Device Design	Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.	254	2014-10-08

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.

Cross-Over Acetabular Shell and Liner System