FDA.reportPublic FDA data

coflex wing loosener

Primary DI
04260148897832
Brand
coflex wing loosener
Company
Paradigm Spine GmbH
Model
UAT40201
Published
2018-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NQOProsthesis, Spinous Process Spacer/Plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQOProsthesis, Spinous Process Spacer/PlateUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P110008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110008000COFLEX® INTERLAMINAR TECHNOLOGYCompanion Spine France2012-10-17NQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260148897832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260148897832042601488978324260148897832

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
537619731
Device count
1
Lot or batch
true
Sterilization required before use
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701521300347DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
03701521300354DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
03701521300361DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
03701521300378DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
03701521300385DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
04260636678998coflex instrument loaner setParadigm Spine GmbHNQO2023-03-31
00884662000529Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2020-09-28
00088466000529Superion Indirect Decompression SystemVERTIFLEX, INC.NQO2019-02-04
00884662000536Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
00884662000543Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
00884662000550Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
00884662000567Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
04260148897825coflex crimping pliers, longParadigm Spine GmbHNQO2018-10-23
04260148897849coflex dual pliersParadigm Spine GmbHNQO2018-10-10
04260148897856coflex MalletParadigm Spine GmbHNQO2018-08-02
04260148897863coflex mallet capParadigm Spine GmbHNQO2018-08-02
04260148897740coflex trial with guide and x-ray marker, 8mmParadigm Spine GmbHNQO2018-06-28
04260148897757coflex trial with guide and x-ray marker, 10mmParadigm Spine GmbHNQO2018-06-28
04260148897764coflex trial with guide and x-ray marker, 12mmParadigm Spine GmbHNQO2018-06-28
04260148897771coflex trial with guide and x-ray marker, 14mmParadigm Spine GmbHNQO2018-06-28
04260148897788coflex trial with guide and x-ray marker, 16mmParadigm Spine GmbHNQO2018-06-28
04260148897795coflex trial slider with wingsParadigm Spine GmbHNQO2018-06-28
04260148897801coflex trial capParadigm Spine GmbHNQO2018-06-28
04260148898594coflex freehand crimping pliersParadigm Spine GmbHNQO2018-06-28
04260148898600coflex extractor pliersParadigm Spine GmbHNQO2018-06-28
04260148898358coflex single-use instrumentsParadigm Spine GmbHNQO2018-06-14
00884662000574Superion™ SUIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2018-04-05
00884662000611Vertiflex™ VIPBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2018-04-05
00884662000123Superion DriverVERTIFLEX, INC.NQO2017-08-16
00884662000130Superion InserterVERTIFLEX, INC.NQO2017-08-16