FDA.reportPublic FDA data

Perfix™ Spinal System

Primary DI
08800037560476
Brand
Perfix™ Spinal System
Company
CG MedTech Co.,Ltd.
Model
SH1940
Published
2023-02-25
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031595000U & I AMERICA SPINAL HOOK SYSTEMU&I Corp., America2003-06-24KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800037560476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800037560476088000375604768800037560476

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

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
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
08800247359945UniSpace® TPLIF CageTU02202026-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606186544OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
00840606186551OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
00613994738646ZEPHIR® Anterior Cervical SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2019-03-07
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
04546540147257XIA IIStryker CorporationKWP2014-12-08
04546540147769XIA IIStryker CorporationKWP2014-12-08
04546540147806XIA IIStryker CorporationKWP2014-12-08
04546540147905XIA IIStryker CorporationKWP2014-12-08
04546540147912XIA IStryker CorporationKWP2014-12-08
04546540147929XIA IStryker CorporationKWP2014-12-08
04546540147936XIA IStryker CorporationKWP2014-12-08
04546540147974XIA IStryker CorporationKWP2014-12-08
04546540147981XIA IStryker CorporationKWP2014-12-08
04546540147998XIA IStryker CorporationKWP2014-12-08
04546540148001XIA IIStryker CorporationKWP2014-12-08
04546540148018XIA IIStryker CorporationKWP2014-12-08
04546540148025XIA IIStryker CorporationKWP2014-12-08