COSY

Basic Information

• Brand Name: COSY
• Primary DI: 04047844098288
• Version / Model: Parallel connector open
• Catalog Number: CA0152-35055
• Company Name: SIGNUS Medizintechnik GmbH
• Labeler DUNS: 344203948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-15
• Public Version: 3
• Public Version Date: 2024-09-11
• Public Version Status: Update
• Public Device Record Key: f8295b19-6e65-4974-81c4-5d69e15668ab

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NKG	Posterior Cervical Screw System	Orthopedic	888.3075	2
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	888.3050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65114	Bone-screw internal spinal fixation system connector	An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04047844098288	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K220658	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Ø3,5mm/5,5mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 35 Degrees Celsius