Cosy

The COSY Cervicothoracic Occipital Rod-Screw is a multiple component, posterior spinal fixations system which consists of solid screws, cannulated screws, standard tulips, angulated tulips,…

Registry build 21.09.26

The COSY Cervicothoracic Occipital Rod-Screw is a multiple component, posterior spinal fixations system which consists of solid screws, cannulated screws, standard tulips, angulated tulips, curved rods, straight rods, hybrid rods, parallel connectors, inline connectors, occipital plates, occipital bone screws, hooks, and offset connectors. All implants, except of variations of the rods, are available in Ti-6AL-4V ELI per ASTM F136. Rods are available in Ti-6AL-4V ELI per ASTM F136 or Co-Cr28-Mo6 per ASTM F1537. The pedicle screws consist of a tulip and a pedicle screw shaft. The shaft has a prominent thread, to provide anchorage of the screw in the pedicle section of the vertebrae. Each tulip is securely attached to the rod via a set screw. The shafts of the pedicle screws are provided in different lengths, diameters, fully or partially threaded, and with a symmetric or asymmetric angulation to provided adaptability to the patient’s anatomy. The rods can be shortened on site by the surgeon. The occipital plate is available with four or five holes and areas to be bent for better fixation to the occipital part of the skull. The plate is fixed via bone screws and as two gliding tulips to provided anchoring of the rod. The gliding tulips are constructed similar to the tulips of the pedicle screws in the area of the rod- set screw -tulip intersection.

4manufacturers in China registered for this device type
550catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

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

Chinese manufacturers registered for FDA product code NKG
Manufacturer City Province Registered as Device types
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Double Medical Technology Inc. Xiamen Fujian Contract manufacturer 14
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10

Record

Regulatory record for Cosy
Listed by Signus Medizintechnik Gmbh, Germany
FDA product code NKG
Device type Posterior Cervical Screw System
Device class Class 2
Regulation 21 CFR 888.3075
Establishment Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k) K220658
Record published 2023-03-15
Record revised 2026-04-23 (version 5)

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
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 0 to 35 °C
Packaging Pack of 2, pack of 4, pack of 5

Catalogue Numbers

Catalogue numbers for Cosy
Catalogue number Size Status
Occiput plate 5-hole, 32x56mm In distribution
Revision occipital screw Ø5,0x14mm In distribution
Tulips cross connector Ø3,5mm,22-30mm In distribution
Shank screw with tulip, cannulated, polyaxial Ø3,5x40mm In distribution
Occiput rod, curved Ø3,5x300mm, 120° In distribution
Shank screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x36mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling Ø4,0x46mm In distribution
Hook, right, incl. set screw In distribution
Screw with tulip, polyaxial Ø4,0x26mm In distribution
Shank screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x42mm In distribution
Shank screw with tulip, cannulated, polyaxial Ø3,5x42mm In distribution
Shank screw with tulip, polyaxial Ø3,5x44mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x32mm In distribution
Screw with tulip, angled, cannulated, polyaxial, incl. set screw Ø4,0x30mm In distribution
Screw with tulip, polyaxial, incl. set screw Ø4,0x32mm In distribution
Revision occipital screw Ø5,0x12mm In distribution
Pedicle screw with tulip, polyaxial, incl. set screw Ø4,5x20mm In distribution
Screw with tulip, polyaxial Ø3,5x14mm In distribution
Shank screw with tulip, polyaxial Ø4,0x24mm In distribution
Screw with tulip, angled, cannulated, polyaxial Ø4,0x30mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø3,5x32mm In distribution
Hook offset connector, left, incl. set screw In distribution
Revision occipital screw Ø5,0x14mm In distribution
Pedicle screw with tulip, polyaxial Ø4,5x35mm In distribution
Screw with tulip, polyaxial, incl. set screw Ø3,5x24mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling Ø3,5x46mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø3,5x30mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling Ø3,5x44mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x12mm In distribution
Shank screw with tulip, polyaxial Ø4,0x42mm In distribution
Set screw tulips cross connector, reduction T15 Ø6,1×20,3mm In distribution
Shank screw with tulip, cannulated, polyaxial Ø3,5x34mm In distribution
Shank screw with tulip, cannulated, polyaxial Ø4,0x34mm In distribution
Screw with tulip, polyaxial Ø4,0x12mm In distribution
Screw with tulip, cannulated, polyaxial Ø4,0x8mm In distribution
Screw with tulip, angled, polyaxial Ø4,0x28mm In distribution
Offsetverbinder, incl. set screw Ø3,5x15mm In distribution
Set screw parallel/inline connector T15 Ø6,1x8mm In distribution
Screw with tulip, polyaxial Ø4,0x8mm In distribution
Revision occipital screw Ø5,0x12mm In distribution
Screw with tulip, cannulated, polyaxial Ø4,0x18mm In distribution
Screw with tulip, polyaxial Ø4,0x32mm In distribution
Pedicle screw with tulip, cannulated, polyaxial Ø4,5x35mm In distribution
Screw with tulip, polyaxial, incl. set screw Ø4,0x22mm In distribution
Cross connector 32-42mm In distribution
Screw with tulip, angled, polyaxial Ø3,5x30mm In distribution
Shank screw with tulip, polyaxial Ø3,5x24mm In distribution
Screw with tulip, angled, polyaxial, self drilling Ø3,5x38mm In distribution
Transition rod, straight Ø3,5mm/6,0mmx600mm In distribution
Pedicle screw with tulip, cannulated, polyaxial, incl. set screw Ø4,5x30mm In distribution
Rod, curved Ø3,5x90mm In distribution
Screw with tulip, cannulated, polyaxial Ø4,0x30mm In distribution
Inferior lamina hook, long, incl. set screw In distribution
Occipital screw Ø4,5x6mm In distribution
Shank screw with tulip, cannulated, polyaxial Ø4,0x26mm In distribution
Pedicle screw with tulip, polyaxial Ø4,5x45mm In distribution
Screw with tulip, polyaxial Ø3,5x28mm In distribution
Screw with tulip, polyaxial Ø3,5x12mm In distribution
Screw with tulip, cannulated, polyaxial Ø4,0x38mm In distribution
Pedicle screw with tulip, polyaxial Ø4,5x20mm In distribution
Shank screw with tulip, cannulated, polyaxial Ø4,0x30mm In distribution
Shank screw with tulip, polyaxial Ø4,0x22mm In distribution
Screw with tulip, angled, polyaxial Ø3,5x20mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling Ø3,5x34mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling Ø3,5x48mm In distribution
Screw with tulip, angled, polyaxial, self drilling Ø4,0x50mm In distribution
Pedicle screw with tulip, polyaxial, incl. set screw Ø4,5x45mm In distribution
Screw with tulip, cannulated, polyaxial Ø3,5x38mm In distribution
Screw with tulip, angled, polyaxial, self drilling Ø4,0x34mm In distribution
Rod, curved Ø3,5x70mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling Ø3,5x40mm In distribution
Occipital screw Ø4,5x12mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø3,5x34mm In distribution
Screw with tulip, polyaxial, incl. set screw Ø3,5x8mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x38mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø3,5x46mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling, incl. set screw Ø4,0x36mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x22mm In distribution
Screw with tulip, angled, polyaxial, self drilling, incl. set screw Ø3,5x36mm In distribution
Screw with tulip, polyaxial Ø3,5x38mm In distribution
Screw with tulip, angled, polyaxial, self drilling, incl. set screw Ø4,0x36mm In distribution
Screw with tulip, cannulated, polyaxial Ø3,5x40mm In distribution
Shank screw with tulip, polyaxial Ø3,5x32mm In distribution
Shank screw with tulip, cannulated, polyaxial Ø3,5x38mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling, incl. set screw Ø4,0x38mm In distribution
Screw with tulip, angled, polyaxial, incl. set screw Ø3,5x30mm In distribution
Rod, curved Ø3,5x80mm In distribution
Screw with tulip, angled, polyaxial Ø4,0x30mm In distribution
Pedicle screw with tulip, cannulated, polyaxial, incl. set screw Ø4,5x40mm In distribution
Atlas hook Ø3,5x100mm In distribution
Shank screw with tulip, polyaxial Ø3,5x38mm In distribution
Rod, straight Ø3,5x120mm In distribution
Shank screw with tulip, polyaxial Ø3,5x20mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø4,0x42mm In distribution
Shank screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x24mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling, incl. set screw Ø4,0x46mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø3,5x44mm In distribution
Screw with tulip, angled, cannulated, polyaxial Ø3,5x22mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø3,5x20mm In distribution
Revision occipital screw Ø5,0x16mm In distribution
Screw with tulip, cannulated, polyaxial Ø3,5x34mm In distribution
Pedicle screw with tulip, polyaxial, incl. set screw Ø4,5x35mm In distribution
Rod, curved Ø3,5x60mm In distribution
Shank screw with tulip, polyaxial Ø4,0x40mm In distribution
Screw with tulip, angled, polyaxial, self drilling Ø3,5x40mm In distribution
Screw with tulip, polyaxial Ø3,5x30mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling, incl. set screw Ø3,5x34mm In distribution
Screw with tulip, angled, polyaxial Ø4,0x24mm In distribution
Screw with tulip, polyaxial, incl. set screw Ø3,5x22mm In distribution
Rod, curved Ø3,5x50mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling Ø4,0x50mm In distribution
Rod, straight Ø3,5x80mm In distribution
Pedicle screw with tulip, cannulated, polyaxial, incl. set screw Ø4,5x45mm In distribution
Parallel connector closed Ø3,5mm/5,5mm In distribution
Rod, curved Ø3,5x80mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x34mm In distribution
Hook offset connector, right, incl. set screw In distribution
Screw with tulip, angled, polyaxial, self drilling, incl. set screw Ø3,5x46mm In distribution
Tulips cross connector Ø3,5mm,38-48mm In distribution
Cross connector 32-42mm In distribution
Pedicle screw with tulip, polyaxial, incl. set screw Ø4,5x25mm In distribution
Occipital screw Ø4,5x16mm In distribution
Screw with tulip, polyaxial Ø4,0x28mm In distribution
Screw with tulip, polyaxial Ø3,5x16mm In distribution
Rod, curved Ø3,5x70mm In distribution
Screw with tulip, angled, polyaxial, self drilling Ø3,5x44mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x18mm In distribution
Transition rod, straight Ø3,5mm/5,5mmx600mm In distribution
Screw with tulip, angled, polyaxial, incl. set screw Ø3,5x24mm In distribution
Rod, curved Ø3,5x40mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø3,5x22mm In distribution
Hook, straight, incl. set screw In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x16mm In distribution
Screw with tulip, polyaxial, incl. set screw Ø3,5x36mm In distribution
Screw with tulip, cannulated, polyaxial Ø4,0x20mm In distribution
Shank screw with tulip, polyaxial Ø4,0x26mm In distribution
Cross connector 26-36mm In distribution
Shank screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x34mm In distribution
Set screw parallel/inline connector T15 Ø6,1x8mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø3,5x26mm In distribution
Screw with tulip, polyaxial Ø4,0x20mm In distribution
Screw with tulip, angled, cannulated, polyaxial, incl. set screw Ø4,0x20mm In distribution
Shank screw with tulip, polyaxial Ø3,5x26mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x8mm In distribution
Rod, curved Ø3,5x40mm In distribution
Screw with tulip, cannulated, polyaxial Ø4,0x26mm In distribution
Shank screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x42mm In distribution
Screw with tulip, angled, polyaxial Ø4,0x26mm In distribution
Screw with tulip, cannulated, polyaxial Ø4,0x24mm In distribution
Rod, curved Ø3,5x30mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling Ø4,0x34mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling, incl. set screw Ø4,0x34mm In distribution
Shank screw with tulip, cannulated, polyaxial Ø4,0x46mm In distribution
Rod, curved Ø3,5x40mm In distribution
Screw with tulip, polyaxial, incl. set screw Ø4,0x38mm In distribution
Set screw T15 Ø6,1×2,8mm In distribution
Pedicle screw with tulip, cannulated, polyaxial, incl. set screw Ø4,5x20mm In distribution
Screw with tulip, angled, polyaxial, self drilling, incl. set screw Ø4,0x38mm In distribution
Transition rod, straight Ø3,5mm/5,5mmx420mm In distribution
Screw with tulip, cannulated, polyaxial Ø3,5x8mm In distribution
Shank screw with tulip, polyaxial Ø3,5x22mm In distribution
Occipital screw Ø4,5x6mm In distribution
Screw with tulip, angled, polyaxial, self drilling Ø4,0x36mm In distribution
Screw with tulip, polyaxial, incl. set screw Ø4,0x20mm In distribution
Screw with tulip, angled, polyaxial Ø4,0x20mm In distribution
Screw with tulip, angled, cannulated, polyaxial, incl. set screw Ø3,5x32mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x14mm In distribution
Rod, straight Ø3,5x240mm In distribution
Occipital screw Ø4,5x16mm In distribution
Screw with tulip, angled, cannulated, polyaxial Ø4,0x22mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling, incl. set screw Ø3,5x36mm In distribution
Shank screw with tulip, cannulated, polyaxial Ø4,0x24mm In distribution
Offset connector Ø3,5x15mm In distribution
Screw with tulip, polyaxial Ø3,5x36mm In distribution
Screw with tulip, cannulated, polyaxial Ø4,0x32mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø4,0x38mm In distribution
Revision occipital screw Ø5,0x6mm In distribution
Shank screw with tulip, polyaxial Ø4,0x38mm In distribution
Screw with tulip, angled, cannulated, polyaxial Ø3,5x26mm In distribution
Screw with tulip, angled, polyaxial, self drilling Ø3,5x42mm In distribution
Screw with tulip, polyaxial Ø3,5x40mm In distribution
Screw with tulip, angled, cannulated, polyaxial Ø3,5x28mm In distribution
Screw with tulip, polyaxial, incl. set screw Ø4,0x34mm In distribution
Shank screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x20mm In distribution
Shank screw with tulip, cannulated, polyaxial Ø3,5x24mm In distribution
Revision occipital screw Ø5,0x6mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø3,5x24mm In distribution
Screw with tulip, angled, polyaxial, self drilling Ø4,0x48mm In distribution
Revision occipital screw Ø5,0x16mm In distribution
Rod, straight Ø3,5x240mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø4,0x32mm In distribution
Shank screw with tulip, polyaxial Ø3,5x28mm In distribution
Rod, straight Ø3,5x240mm In distribution
Rod, straight Ø3,5x120mm In distribution
Screw with tulip, angled, cannulated, polyaxial, incl. set screw Ø4,0x22mm In distribution
Screw with tulip, angled, cannulated, polyaxial, incl. set screw Ø4,0x28mm In distribution
Screw with tulip, angled, polyaxial, self drilling, incl. set screw Ø3,5x44mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling, incl. set screw Ø3,5x38mm In distribution
Shank screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x22mm In distribution
Screw with tulip, angled, polyaxial, self drilling Ø3,5x50mm In distribution
Pedicle screw with tulip, cannulated, polyaxial, incl. set screw Ø4,5x25mm In distribution
Screw with tulip, angled, cannulated, polyaxial Ø3,5x20mm In distribution
Rod, curved Ø3,5x90mm In distribution
Rod, straight Ø3,5x360mm In distribution
Pedicle screw with tulip, cannulated, polyaxial Ø4,5x50mm In distribution
Rod, curved Ø3,5x90mm In distribution
Tulips cross connector, incl. set screws/retaining nuts Ø3,5mm,32-42mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x20mm In distribution
Screw with tulip, cannulated, polyaxial Ø3,5x30mm In distribution
Screw with tulip, angled, polyaxial, self drilling, incl. set screw Ø3,5x34mm In distribution
Set screw tulips cross connector T15 Ø6,1x8mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x12mm In distribution
Shank screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x46mm In distribution
Cross connector 44-52mm In distribution
Cross connector 22-30mm In distribution
Shank screw with tulip, cannulated, polyaxial, incl. set screw Ø4,0x32mm In distribution
Screw with tulip, polyaxial Ø3,5x26mm In distribution
Pedicle screw with tulip, polyaxial Ø4,5x50mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x30mm In distribution
Screw with tulip, polyaxial Ø3,5x24mm In distribution
Shank screw with tulip, cannulated, polyaxial Ø4,0x28mm In distribution
Shank screw with tulip, polyaxial, incl. set screw Ø3,5x36mm In distribution
Parallel connector open Ø3,5mm/6,0mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x28mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling, incl. set screw Ø4,0x50mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x32mm In distribution
Pedicle screw with tulip, cannulated, polyaxial Ø4,5x40mm In distribution
Screw with tulip, cannulated, polyaxial Ø4,0x22mm In distribution
Pedicle screw with tulip, polyaxial Ø4,5x40mm In distribution
Screw with tulip, angled, polyaxial, self drilling, incl. set screw Ø4,0x40mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling, incl. set screw Ø3,5x46mm In distribution
Shank screw with tulip, polyaxial Ø3,5x34mm In distribution
Occipital screw Ø4,5x10mm In distribution
Set screw T15 Ø6,1×2,8mm In distribution
Shank screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x26mm In distribution
Shank screw with tulip, cannulated, polyaxial Ø3,5x44mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x18mm In distribution
Screw with tulip, angled, cannulated, polyaxial, self drilling, incl. set screw Ø3,5x50mm In distribution
Rod, curved Ø3,5x40mm In distribution
Shank screw with tulip, polyaxial Ø4,0x20mm In distribution
Shank screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x30mm In distribution
Screw with tulip, polyaxial, incl. set screw Ø3,5x16mm In distribution
Shank screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x34mm In distribution
Pedicle screw with tulip, cannulated, polyaxial Ø4,5x30mm In distribution
Occipital screw Ø4,5x10mm In distribution
Screw with tulip, polyaxial, incl. set screw Ø3,5x28mm In distribution
Shank screw with tulip, polyaxial Ø4,0x34mm In distribution
Screw with tulip, cannulated, polyaxial, incl. set screw Ø3,5x34mm In distribution
Screw with tulip, polyaxial, incl. set screw Ø3,5x18mm In distribution
Screw with tulip, angled, polyaxial, incl. set screw Ø4,0x32mm In distribution

Showing 250 of 300 catalogue numbers.

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Showing 12 of 336. All products under Posterior Cervical Screw System

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K220658 2022-11-18

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