FDA.reportPublic FDA data

AnyPlus® Cervical PEEK Cage System

Primary DI
08809885799816
Brand
AnyPlus® Cervical PEEK Cage System
Company
GS Medical Co., Ltd.
Model
GS110-1950
Catalog number
GS110-1950
Device description
AnyPlus Persuader
Published
2025-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXCWrench

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809885799816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809885799816088098857998168809885799816

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82432377393udimail@gsmedi.com

Regulatory Flags#

DUNS number
688385418
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800322693100VEGA Cervical Screw System0866-10300866-10302026-09-30
08800322693117VEGA Cervical Screw System0866-1030-M00866-1030-M02026-09-30
08800322693124VEGA Cervical Screw System0866-10350866-10352026-09-30
08800322693131VEGA Cervical Screw System0866-1035-M00866-1035-M02026-09-30
08800322693148VEGA Cervical Screw System0866-10400866-10402026-09-30
08800322693155VEGA Cervical Screw System0866-1040-M00866-1040-M02026-09-30
08800322693162VEGA Cervical Screw System0866-10450866-10452026-09-30
08800322693179VEGA Cervical Screw System0866-1045-M00866-1045-M02026-09-30
08800322693186VEGA Cervical Screw System0866-10500866-10502026-09-30
08800322693193VEGA Cervical Screw System0866-1050-M00866-1050-M02026-09-30
08800322693209VEGA Cervical Screw System0866-10550866-10552026-09-30
08800322693216VEGA Cervical Screw System0866-1055-M00866-1055-M02026-09-30
08800322693223VEGA Cervical Screw System0866-10600866-10602026-09-30
08800322693230VEGA Cervical Screw System0866-1060-M00866-1060-M02026-09-30
08800322693247VEGA Cervical Screw System0866-10650866-10652026-09-30
08800322693254VEGA Cervical Screw System0866-1065-M00866-1065-M02026-09-30
08800322693261VEGA Cervical Screw System0866-10700866-10702026-09-30
08800322693278VEGA Cervical Screw System0866-1070-M00866-1070-M02026-09-30
08800322693285VEGA Cervical Screw System0866-10750866-10752026-09-30
08800322693292VEGA Cervical Screw System0866-1075-M00866-1075-M02026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846010722Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2026-10-09
03701089527927AMPLITUDEAMPLITUDE SASHXC2026-07-29
03701089540759AMPLITUDEAMPLITUDE SASHXC2026-07-29
00763000837181Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.HXC2026-07-17
18257200066810PROVIEWOrthofix US LLCHXC2026-07-17
00817247023323MedTorqueArch Medical Solutions Corp.HXC2026-06-30
00817247024559MedTorqueArch Medical Solutions Corp.HXC2026-06-30
B756007053001000Torque WrenchShukla MedicalHXC2026-06-01
10886982362964NASynthes GmbHHXC2026-05-04
08059386742273Orthopaedic Surgical InstrumentsCITIEFFE SRLHXC2025-11-05
1085007050056915mm CurvaFix Hex Wrench CURVAFIX, INC.HXC2025-10-22
10889981437794SpecialsSeaspine Orthopedics CorporationHXC2025-10-17
18059015376494ORTHOFIXORTHOFIX SRLHXC2025-03-31
08800104097966Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXC2025-03-17
08809885799762Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXC2025-03-17
18059015376029TRUELOK SYSTEMORTHOFIX SRLHXC2025-01-10
00817247023491MedTorqueArch Medical Solutions Corp.HXC2024-11-08
10840199540805Modified Kaufman Type Kidney ClampKOROS U.S.A., INC.HXC2024-01-31
00841732144309GENERIC Surgical InstrumentsCTL Medical CorporationHXC2023-09-15
08800068966230LOSPA Modular Knee SystemCorentec Co., LtdHXC2022-10-24
08800068964960LOSPA Modular Knee System Corentec Co., LtdHXC2022-10-23
10845854023976ULTRAPOWERConmed CorporationHXC2022-06-02
B07301K0360280Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380000Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380010Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380020Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380030Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380200Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
10886982195722NASynthes GmbHHXC2019-02-21
08809265159063Surgical InstrumentJeil Medical CorporationHXC2018-11-28