Hoffmann

Inverted Pin To Rod Coupling 4-5,8mm

Registry build 21.09.26
6manufacturers in China registered for this device type
26catalogue 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 Hoffmann
Listed by Stryker GmbH, Switzerland
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 Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
510(k) K051306
Record published 2018-09-24
Record revised 2026-06-24 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Sizes Length 65 to 500 mm; angle 30 °
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Hoffmann
Catalogue number Size Status
5029-8-400 Length 400.0 mm In distribution
5029-8-250 Diameter: 8.0 Millimeter In distribution
5029-8-300 Length 300.0 mm In distribution
4921-0-015 Diameter: 20.0 Millimeter In distribution
5028-8-300 Diameter: 8.0 Millimeter In distribution
5029-8-500 Diameter: 8.0 Millimeter In distribution
5029-8-100 Length 100.0 mm In distribution
4921-2-060 Screw Holes: 10.0 Holes In distribution
4921-2-020 Screw Holes: 5.0 Holes In distribution
5029-8-350 Diameter: 8.0 Millimeter In distribution
5028-7-030 Length 174.0 mm In distribution
5028-8-500 Length 500.0 mm In distribution
4921-1-100 In distribution
5029-8-065 Diameter: 8.0 Millimeter In distribution
4921-1-010 In distribution
4921-2-140 Angle 30.0 ° In distribution
5028-8-400 Length 400.0 mm In distribution
4920-2-080 In distribution
5029-8-150 Length 150.0 mm In distribution
5028-8-100 Diameter: 8.0 Millimeter In distribution
5029-8-450 Diameter: 8.0 Millimeter In distribution
4920-9-930 In distribution
4921-1-030 In distribution
4921-2-080 In distribution
4921-1-020 In distribution
5028-8-200 Diameter: 8.0 Millimeter 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
Arbor Globus Medical, Inc. 46
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

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