FDA.reportPublic FDA data

CoFix Implant 10 mm

Primary DI
04260148898242
Brand
CoFix Implant 10 mm
Company
Paradigm Spine GmbH
Model
RQI00010
Catalog number
RQI00010
Published
2020-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PEKSpinous Process Plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEKSpinous Process PlateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153302000coflex-IFParadigm Spine, LLC2016-09-08PEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260148898242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260148898242042601488982424260148898242

GMDN Terms#

Term, Definition table
TermDefinition
Interspinous spinal fixation implantAn implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height10Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
537619731
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260148896927DSS HP Polyaxial pedicle screw set, Ø5 x 45mm HPI850452015-10-01
04260148892516DSS NutDPI060112015-10-01
04260148892523DSS Rigid coupler, 20mmDPI700202015-10-01
04260148892554DSS Slotted coupler, 50N/mm stiffness, 26mm longDPI350262015-10-01
04260148892561DSS Slotted coupler, 50N/mm stiffness, 28mm longDPI350282015-10-01
04260148892578DSS Slotted coupler, 50N/mm stiffness, 31mm longDPI350312015-10-01
04260148892585DSS Slotted coupler, 50N/mm stiffness, 35mm longDPI350352015-10-01
04260148892592DSS Rigid coupler, 22-25mmDPI700222015-10-01
04260148892608DSS Rigid coupler, 25-31mmDPI70025 2015-10-01
04260148892615DSS Rigid coupler, 31-43 mmDPI700312015-10-01
04260148892677DSS Pedicle screw set, Ø5.0 x 30mmDPI450302015-10-01
04260148892684DSS Pedicle screw set, Ø5.0 x 35mmDPI450352015-10-01
04260148892691DSS Pedicle screw set, Ø5.0 x 40mmDPI450402015-10-01
04260148892707DSS Pedicle screw set, Ø5.0 x 45mmDPI45045 2015-10-01
04260148892714 DSS Pedicle screw set, Ø5.0 x 50mmDPI450502015-10-01
04260148892721DSS Pedicle screw set, Ø5.0 x 55mmDPI450552015-10-01
04260148892738DSS Pedicle screw set, Ø5.0 x 60mmDPI450602015-10-01
04260148892745DSS Pedicle screw set, Ø6.0 x 30mmDPI46030 2015-10-01
04260148892752DSS Pedicle screw set, Ø6.0 x 35mmDPI46035 2015-10-01
04260148892769DSS Pedicle screw set, Ø6.0 x 40mmDPI460402015-10-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B1830712181100KeyLift™FLOSPINE LLCPEK2025-02-03
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10889981096298GeneralSeaspine Orthopedics CorporationPEK2024-06-11
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00190837137090Aileron TRXLife Spine, Inc.PEK2022-07-11
M9431001040000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13
M9431001000000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13
M9431001010000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13
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