ResCUBE™

Primary DI
03760185576109
Brand
ResCUBE™
Company
COUSIN BIOTECH
Model
RCBCUBETUU
Device description
The ResCUBE™ System is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. It consists of: - A ligament allowing correction and stabilization of the levels, after tensioning - A malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath. The lamella and shrink sleeve are not intended for long term implantation and must be removed after placement of the implant. - A low-profile connector holding the tension on the ligament
Published
2024-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWIBone Fixation Cerclage, Sublaminar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWIBone Fixation Cerclage, SublaminarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181799000ResCUBE™ Ligament Fixation SystemCousin Biotech Sas2018-08-29OWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760185576109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760185576109037601855761093760185576109

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation system cableAn implantable fixation device designed to apply a force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically made of braided medical grade titanium (Ti) and stainless steel alloy of various lengths and designs (e.g., it may be supplied with or without attached fasteners). The cable is tightened with a tension device and is fastened or crimped at each eye-type screw.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33320144120serviceclients@cousin-surgery.com

Regulatory Flags#

DUNS number
776742439
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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037601855723234DDOME ®4DDOME24SR2015-10-23
037601855723474DDOME ®4DDOME30SR2015-10-23
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037601855729274DDOME®4DDOM24GSR2015-10-23
037601855729344DDOME ®4DDOM30GSR2015-10-23
037601855729414DDOME ®4DDOM38GSR2015-10-23

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