Who else makes this device?

Name: 3.5mm x 46mm Cortex Screw
Brand: 3.5mm x 46mm Cortex Screw

Orthopedic › ProstheticNail, Fixation, Bone

3.5mm X 46mm Cortex Screw

Catalogue number SC3546, listed by Conventus Orthopaedics, Inc., United States, under Nail, Fixation, Bone. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JDS
Manufacturer	City	Province	Registered as	Device types
LX Precision Shanghai Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54

Record

Regulatory record for 3.5mm x 46mm Cortex Screw
Listed by	Conventus Orthopaedics, Inc., United States
FDA product code	JDS
Device type	Nail, Fixation, Bone
Device class	Class 2
Regulation	21 CFR 888.3030
Record published	2017-09-22
Record revised	2024-02-19 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for 3.5mm x 46mm Cortex Screw
Catalogue number	Size	Status
SC3546		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Autobahn	Globus Medical, Inc.	1,102
Trigen	Smith & Nephew, Inc.	1,062
Nail, Fixation, Bone	Synthes Gmbh	296
Nail, Fixation, Bone	Synthes (U.S.A.) LP	237
Intertan MAX	Smith & Nephew, Inc.	235
EXPert Nail	Synthes Gmbh	225
Trigen MAX	Smith & Nephew, Inc.	172
Ajax Nail	Auxein medical Private limited	168
GPC	GPC Medical Limited	155
130° Ga-mma Nail	Auxein medical Private limited	90
Ender Nail	Smith & Nephew, Inc.	82
Centronail Titanium Humeral Nailing System	Orthofix SRL	79

Showing 12 of 112. All products under Nail, Fixation, Bone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K141737	2015-04-08

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.