The Bump

Positioner - wedge

Registry build 21.09.26
3manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Hebei (1), Sichuan (1), Shanghai (1).

Chinese manufacturers registered for FDA product code JEB
Manufacturer City Province Registered as Device types
Hebei Ruinuo Medical Instrument Co Ltd Shijiazhuang Hebei Manufacturer 29
Chengdu Ruinuo Meijer Medical Instrument Co., Ltd. Chengdu Sichuan Manufacturer 11
Shanghai PAX Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 7

Record

Regulatory record for the bump
Listed by General Hospital Supply Corp., United States
FDA product code JEB
Device type Table, Surgical With Orthopedic Accessories, Manual
Device class Class 1
Regulation 21 CFR 878.4950
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2022-09-20

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes

Catalogue Numbers

Catalogue numbers for the bump
Catalogue number Size Per pack Status
4411 72 In distribution
495 25 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Spica Table Orthopediatrics, Corp 34
Alliant Biotech Medisurge, LLC 19
Schaerer Medical USA Schaerer Medical USA Inc 12
Prone Perfect Orthopediatrics, Corp 11
Assi Accurate Surgical & Scientific Instruments Corp. 10
Table, Surgical With Orthopedic Accessories, Manual Depuy Spine, Inc. 9
Teligen Medos International Sàrl 3
General Instruments Orthopediatrics, Corp 3
X-Ray Top Head Section Jörg & Sohn GmbH 2
X-Ray Top Seat Section TS7000 Jörg & Sohn GmbH 2
Emerson Knee Bump Biomet Orthopedics 2
X-Ray Top Back Section TS7000 Jörg & Sohn GmbH 2

Showing 12 of 32. All products under Table, Surgical With Orthopedic Accessories, Manual

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer