FDA.reportPublic FDA data

Velofix™ SA Cervical Cage

Primary DI
08800037574725
Brand
Velofix™ SA Cervical Cage
Company
CG MedTech Co.,Ltd.
Model
TS0912
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800037574725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800037574725088000375747258800037574725

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
Manufacturing date on label
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
00889024699854IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699861IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699878IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699885IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699892IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699908IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699915Comprehensive HumeralZimmer, Inc.FSM2026-10-21
00889024699922Identity HumeralZimmer, Inc.FSM2026-10-21
00889024699939N/AZimmer, Inc.FSM2026-10-20
00889024699946N/AZimmer, Inc.FSM2026-10-20
00889024699953Alliance Glenoid, Identity HumeralZimmer, Inc.FSM2026-10-20
00810111228428Instrument TrayTreace Medical Concepts, Inc.FSM2026-10-16
00810161900909EARP IMPLANT TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900916EARP INSTRUMENT TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900923EARP INSTRUMENT AND IMPLANT LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900930EARP RETRACTOR TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900947EARP RETRACTOR LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900954EARP, TRIAL CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900961EARP, TRIAL LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900978EARP, DISC SPACER CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900985EARP, DISC SPACER LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901746EARP INSTRUMENT #2 TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901753EARP INSTRUMENT #2 LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901814EARP, PLATFORM CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901821EARP, PLATFORM LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
04042409457203CHBSaap Implantate AGFSM2026-10-16
04042409457289CHBSaap Implantate AGFSM2026-10-16
04042409457302CHBSaap Implantate AGFSM2026-10-16
04042409457326CHBSaap Implantate AGFSM2026-10-16
04042409457340CHBSaap Implantate AGFSM2026-10-16