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
08800308485811ANAX™ OCT SPINAL SYSTEMOSS07502026-05-13
08800037574725Velofix™ SA Cervical CageTS09122026-05-06
08800037574732Velofix™ SA Cervical CageTS09132026-05-06
08800308485804ANAX™ OCT Spinal SystemOS00902026-04-21
08800247357477SECULOK™ ACP SYSTEMFCA10192026-03-31
08800247357484SECULOK™ ACP SYSTEMFCA10212026-03-31
08800247357491SECULOK™ ACP SYSTEMFCA10232026-03-31
08800247357507SECULOK™ ACP SYSTEMFCA10252026-03-31
08800247357514SECULOK™ ACP SYSTEMFCA10272026-03-31
08800247357521SECULOK™ ACP SYSTEMFCA10292026-03-31
08800247357538SECULOK™ ACP SYSTEMFCA10312026-03-31
08800247357545SECULOK™ ACP SYSTEMFCA10332026-03-31
08800247357552SECULOK™ ACP SYSTEMFCA10352026-03-31
08800247357569SECULOK™ ACP SYSTEMFCA10372026-03-31
08800247357576SECULOK™ ACP SYSTEMFCA10392026-03-31
08800247357583SECULOK™ ACP SYSTEMFCA10412026-03-31
08800247357590SECULOK™ ACP SYSTEMFCA10432026-03-31
08800247357606SECULOK™ ACP SYSTEMFCA10452026-03-31
08800247357613SECULOK™ ACP SYSTEMFCA20312026-03-31
08800247357620SECULOK™ ACP SYSTEMFCA20332026-03-31

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