AccessGUDID - DEVICE: COSY (04047844110003)

GUDID

Device Identifier (DI) Information

Brand Name: COSY
Version or Model: Screw with tulip, angled, polyaxial
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CA3121-35032
Company Name: SIGNUS Medizintechnik GmbH

Primary DI Number: 04047844110003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344203948 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46651	Spinal bone screw, non-bioabsorbable	A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NKG	Posterior Cervical Screw System
KWP	Appliance, Fixation, Spinal Interlaminal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220658	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Ø3,5x32mm

Device Record Status

Public Device Record Key: 7b3216e4-eb05-4391-88f6-1fd58112b1c5
Public Version Date: September 11, 2024
Public Version Number: 3
DI Record Publish Date: March 20, 2023