FDA.reportPublic FDA data

Polarfix™ Facet Screw System

Primary DI
08800015994705
Brand
Polarfix™ Facet Screw System
Company
CG MedTech Co.,Ltd.
Model
FSA4540
Published
2018-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRWSYSTEM, FACET SCREW SPINAL DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173198000Facet Screw Fixation SystemU&I Corporation2018-01-03MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800015994705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800015994705088000159947058800015994705

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, single-useA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811082
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800308479131ANAX OCT SPINAL SYSTEMOSS07702026-10-14
08800037575166ANAX™ 5.5 SPINAL SYSTEMSF09612026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMSF09622026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMSF09632026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMSF09602026-09-04
08800308479070ANAX™ 5.5 CT SPINAL SYSTEMCTS02202026-08-19
08800308479094ANAX™ 5.5 CT SPINAL SYSTEMCTS02402026-08-19
08800308479117ANAX™ 5.5 CT SPINAL SYSTEMCTS02602026-08-19
08800247359822UniSpace® TPLIF CageTU02902026-06-27
08800247359839UniSpace® TPLIF CageTU03002026-06-27
08800247359846UniSpace® TPLIF CageTU03102026-06-27
08800247359853UniSpace® TPLIF CageTU03202026-06-27
08800247359860UniSpace® TPLIF CageTU03302026-06-27
08800247359877UniSpace® TPLIF CageTU03402026-06-27
08800247359884UniSpace® TPLIF CageTU03502026-06-27
08800247359891UniSpace® TPLIF CageTU01702026-06-27
08800247359907UniSpace® TPLIF CageTU01802026-06-27
08800247359914UniSpace® TPLIF CageTU01902026-06-27
08800247359921UniSpace® TPLIF CageTU02002026-06-27
08800247359938UniSpace® TPLIF CageTU02102026-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852776006249CORUS PCSS 3D-T Implant, 4mmProvidence Medical Technology, Inc.MRW2026-10-26
00852776006744CORUS PCSS 3D-T Implant, 5mmProvidence Medical Technology, Inc.MRW2026-10-26
00852776006751CORUS PCSS 3D-T LevelOne, 4mmProvidence Medical Technology, Inc.MRW2026-10-26
00888867614543Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614550Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614567Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614574Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614581Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614598Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614604Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614611Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614628Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614635Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614642Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614659Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614666Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614673Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614680Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614697Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614703Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614710Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614727Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614734Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614741Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614758Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614765Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614772Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614789Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614796Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614802Arthrex®ARTHREX, INC.MRW2026-10-07