FDA.reportPublic FDA data

ANAX™ 5.5 SPINAL SYSTEM

Primary DI
08800037583840
Brand
ANAX™ 5.5 SPINAL SYSTEM
Company
CG MedTech Co.,Ltd.
Model
SFMS0320
Published
2023-12-04
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
HWNINSTRUMENT, COMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800037583840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800037583840088000375838408800037583840

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
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
00840311251148Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251155Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251162Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251179Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251377Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311262953Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-27
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWN2026-03-30
00840311245451Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-03-18
00810111226691Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-02-20
00818345029774RIVA Posterior Fixation SystemXENIX MEDICAL LLCHWN2026-01-12
00810111226677Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00810111226684Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00810111226707Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
15060238201596Femoral Cement PressuriserSUMMIT MEDICAL LIMITEDHWN2025-01-10
00840298704637Songer® Spinal Cable SystemPioneer Surgical Technology, Inc.HWN2024-08-23
00841732164246GENERIC Surgical InstrumentsCTL Medical CorporationHWN2023-09-15
00841732164185GENERIC Surgical InstrumentsCTL Medical CorporationHWN2023-09-14
00643169350991Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWN2022-10-08
G079C5060000010Golden Isles Pedicle Screw SystemIntelivation, LLCHWN2022-09-23
00613994878137n/aMEDTRONIC SOFAMOR DANEK, INC.HWN2022-08-06
00721902875755N/AMEDTRONIC SOFAMOR DANEK, INC.HWN2022-08-06
20886982313437NASynthes GmbHHWN2022-07-29
20886982313444NASynthes GmbHHWN2022-07-29
20886982313451NASynthes GmbHHWN2022-07-29
20886982313468NASynthes GmbHHWN2022-07-29
20886982313475NASynthes GmbHHWN2022-07-29
20886982313482NASynthes GmbHHWN2022-07-29
20886982313499NASynthes GmbHHWN2022-07-29
20886982313505NASynthes GmbHHWN2022-07-29
20886982313512NASynthes GmbHHWN2022-07-29