FDA.reportPublic FDA data

Perfix™ Spinal System

Primary DI
08800037521163
Brand
Perfix™ Spinal System
Company
CG MedTech Co.,Ltd.
Model
SNS0023
Published
2019-10-25
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
HZXSILVER NITRATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HZXSilver NitrateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800037521163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800037521163088000375211638800037521163

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811082
Device count
1
Premarket 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
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
08800247359952UniSpace® TPLIF CageTU02302026-06-27
08800247359969UniSpace® TPLIF CageTU02402026-06-27
08800247359976UniSpace® TPLIF CageTU02502026-06-27
08800247359983UniSpace® TPLIF CageTU02602026-06-27
08800247359990UniSpace® TPLIF CageTU02702026-06-27
08800308485811ANAX™ OCT SPINAL SYSTEMOSS07502026-05-13
08800037574725Velofix™ SA Cervical CageTS09122026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10649111104084SklarSKLAR CORPORATIONHZX2019-08-02
10649111042515SklarSKLAR CORPORATIONHZX2019-04-30
10649111043123SklarSKLAR CORPORATIONHZX2019-04-30
10649111043864SklarSKLAR CORPORATIONHZX2019-04-30
10649111044694SklarSKLAR CORPORATIONHZX2019-04-30
10649111045479SklarSKLAR CORPORATIONHZX2019-04-30
10649111048012SklarSKLAR CORPORATIONHZX2019-04-30
10649111048975SklarSKLAR CORPORATIONHZX2019-04-30
10649111049828SklarSKLAR CORPORATIONHZX2019-04-30
10649111050510SklarSKLAR CORPORATIONHZX2019-04-30
10649111052293SklarSKLAR CORPORATIONHZX2019-04-30
10649111054389SklarSKLAR CORPORATIONHZX2019-04-30
10649111055539SklarSKLAR CORPORATIONHZX2019-04-30
10649111056482SklarSKLAR CORPORATIONHZX2019-04-30
10649111111310SklarSKLAR CORPORATIONHZX2019-04-26
10649111113833SklarSKLAR CORPORATIONHZX2019-04-26
10649111103919SklarSKLAR CORPORATIONHZX2019-04-17
10649111007699SklarSKLAR CORPORATIONHZX2019-03-19