COSY

Primary DI
04047844111178
Brand
COSY
Company
SIGNUS Medizintechnik GmbH
Model
Occiput rod, variable angle
Catalog number
CA5835-00085/S
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.
Published
2023-03-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220658000COSY Cervicothoracic Occipital Rod-Screw SystemSignus Medizintechnik GmbH2022-11-18NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047844111178PackageGS12In Commercial Distribution
04047844111185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844111178040478441111784047844111178
04047844111185040478441111854047844111185

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49602391660info@signus.com

Regulatory Flags#

DUNS number
344203948
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04047844129241DIPLOMATThreaded awl cannulated, obturatorAC00882026-05-20
04047844129258DIPLOMATThreaded awl cannulated, obturatorAC00892026-05-20
04047844102596COSYCross connectorCA0155-38048/S2023-03-21
04047844102602COSYCross connectorCA0155-44052/S2023-03-21
04047844098479COSYRetaining nut tulips cross connectorCA0160-002002023-03-15
04047844127063COSYTray, lidCB03AY-LID-12026-04-22
04047844098707COSYOcciput plateCA0005-320562023-03-15
04047844116432COSYObturatorwireCB0101-32023-03-15
04047844116449COSYGuide wire, round/roundCB01442023-03-15
04047844129272INSTRUMENTTray, instrumentsP009AY2026-02-11
04047844129289INSTRUMENTTray, insert, instrumentsP009AZ2026-02-11
04047844129296COSYTray, implantsCA01AY2026-02-11
04047844129302COSYTray, insert, implantsCA01AZ2026-02-11
04047844129319COSYTray, implantsCA02AY2026-02-11
04047844129326COSYRack, screwsCA1235AZ2026-02-11
04047844129333COSYRack, screwsCA1240AZ2026-02-11
04047844129340COSYRack, screwsCA1245AZ2026-02-11
04047844129357COSYRack, shank screwsCA1735AZ2026-02-11
04047844129364COSYRack, shank screwsCA1740AZ2026-02-11
04047844129371COSYRack, screws angledCA3235AZ2026-02-11

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Primary DI, Brand, Company table
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