Arbor

Schanz Pin, Self-Drilling, 5x180mm, 40mm Cortical Thread, CoCr

Registry build 21.09.26
6manufacturers in China registered for this device type
46catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LXT
Manufacturer City Province Registered as Device types
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70

Record

Regulatory record for Arbor
Listed by Globus Medical, Inc., United States
FDA product code LXT
Device type Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Device class Class 2
Regulation 21 CFR 888.3030
Establishment Manufacturer, Exporter
510(k) K172438
Record published 2018-04-27
Record revised 2021-11-23 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Label carries lot or batch number
Sizes Length 300 to 650 mm

Catalogue Numbers

Catalogue numbers for Arbor
Catalogue number Size Status
7173.3200 Thread Diameter, 3mm In distribution
2173.2503 Overall Length, 150mm In distribution
1173.2303 Thread Diameter, 4mm In distribution
2173.0407 Overall Length, 350mm In distribution
2173.3200 Overall Length, 90mm In distribution
7173.0408 Overall Length, 400mm In distribution
2173.6404 Thread Diameter, 5mm In distribution
5173.1160 Length 600 mm In distribution
1173.5604 Thread Length, 60mm In distribution
5173.1150 Length 500 mm In distribution
1173.0030 In distribution
2173.0408 Overall Length, 400mm In distribution
2173.8704 Overall Length, 200mm In distribution
5173.1135 Length 350 mm In distribution
7173.5404 Overall Length, 200mm In distribution
7173.5503 Thread Diameter, 5mm In distribution
5173.2134 In distribution
2173.9505 Thread Length, 50mm In distribution
2173.4404 Overall Length, 200mm In distribution
2173.6503 Thread Length, 50mm In distribution
7173.6403 Thread Length, 40mm In distribution
2173.8405 Thread Diameter, 6mm In distribution
7173.8605 Thread Length, 60mm In distribution
2173.3303 Overall Length, 150mm In distribution
7173.8405 Thread Length, 40mm In distribution
7173.0407 Thread Length, 40mm In distribution
5173.3180 In distribution
2173.2200 Overall Length, 90mm In distribution
2173.8705 Thread Diameter, 6mm In distribution
7173.2200 Thread Diameter, 3mm In distribution
1173.2251 Thread Diameter, 4mm In distribution
1173.5603 Overall Length, 180mm In distribution
2173.2250 Thread Diameter, 3mm In distribution
5173.1165 Length 650 mm In distribution
1173.8502 Thread Length, 50mm In distribution
5173.1130 Length 300 mm In distribution
1173.5403 Overall Length, 180mm In distribution
2173.9405 Thread Length, 40mm In distribution
1173.2504 Overall Length, 180mm In distribution
1173.8504 Thread Diameter, 6mm In distribution
2173.3250 Thread Length, 25mm In distribution
2173.5503 Overall Length, 180mm In distribution
2173.2403 Thread Length, 40mm In distribution
2173.7503 Thread Length, 50mm In distribution
5173.1155 Length 550 mm In distribution
7173.8705 Thread Length, 70mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
True/LOK Monolateral/Bilateral Fixator Orthofix SRL 206
Truelok System Orthofix SRL 138
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Synthes Gmbh 60
TrueLok Evo Orthofix SRL 60
IJS Skeletal Dynamics L.L.C. 48
Multi-Directional Screw Biomet Orthopedics 44
LCP Synthes Gmbh 40
Lock Screw Square Drive Biomet Orthopedics 40
Smooth PEG Biomet Orthopedics 33
A.l.p.s.® Biomet Orthopedics 32
Cannulated Cancellous LAG Screw Biomet Orthopedics 31
Smooth Locking PEG Biomet Orthopedics 28

Showing 12 of 261. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

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