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.

MobileLink Acetabular Cup System - Instruments · Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented → Orthopedic

Name: MobileLink Acetabular Cup System - Instruments
Brand: MobileLink Acetabular Cup System - Instruments

8manufacturers in China registered for this device type

2catalogue numbers in this listing

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 MobileLink Acetabular Cup System – Instruments
Listed by	Waldemar Link GmbH & Co. KG, Germany
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	Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K200607
Record published	2023-04-27
Record revised	2024-09-11 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for MobileLink Acetabular Cup System – Instruments
Catalogue number	Size	Status
183-950/01		In distribution
183-169/02		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 Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of MobileLink Acetabular Cup System – Instruments
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Waldemar Link GmbH & Co. KG	510(k) number	2023-07-14	Class II	Under Investigation by firm	Product is labeled with incorrect offset.	8 units

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.

MobileLink Acetabular Cup System – Instruments