FDA.reportPublic FDA data

Anyplus II Spinal Fixation System

Primary DI
08809885726911
Brand
Anyplus II Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
GS120-1530
Catalog number
GS120-1530
Device description
Anyplus II In-Situ Bender, Right
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
HXWBender

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809885726911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809885726911088098857269118809885726911

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. 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
08800322709924VEGA Cervical Screw SystemGTI0108-0003GTI0108-00032026-09-22
08800322709993VEGA Cervical Screw SystemGS128-1600GS128-16002026-09-22
08800322719015VEGA Cervical Screw SystemGS128-0700GS128-07002026-09-22
08800322719022VEGA Cervical Screw SystemGS128-1730GS128-17302026-09-22
08800322759639VEGA Cervical Screw SystemGS128-1010GS128-10102026-09-22
08800322759646VEGA Cervical Screw SystemGS128-1011GS128-10112026-09-22
08800322759653VEGA Cervical Screw SystemGS128-1012GS128-10122026-09-22
08800322759660VEGA Cervical Screw SystemGS128-1013GS128-10132026-09-22
08800322759677VEGA Cervical Screw SystemGS128-1014GS128-10142026-09-22
08800322759684VEGA Cervical Screw SystemGS128-1560GS128-15602026-09-22
08800322759691VEGA Cervical Screw SystemGS128-9000GS128-90002026-09-22
08800322759707VEGA Cervical Screw SystemGS128-9100GS128-91002026-09-22
08800322759714VEGA Cervical Screw SystemGS128-9110GS128-91102026-09-22
08809885759667VEGA Cervical Screw SystemGS128-9011GS128-90112026-09-22
08809885759674VEGA Cervical Screw SystemGS128-9012GS128-90122026-09-22
08809885759797VEGA Cervical Screw SystemGS128-9015GS128-90152026-09-22
08809974779408VEGA Cervical Screw SystemGS128-0200GS128-02002026-09-22
08809974779415VEGA Cervical Screw SystemGS128-0300GS128-03002026-09-22
08809974779422VEGA Cervical Screw SystemGS128-0310GS128-03102026-09-22
08809974779439VEGA Cervical Screw SystemGS128-0320GS128-03202026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887587078496NASynthes GmbHHXW2026-08-26
00840536822871Response SpineORTHOPEDIATRICS CORP.HXW2026-08-21
00840536822888Response SpineORTHOPEDIATRICS CORP.HXW2026-08-21
00840536822895Response SpineORTHOPEDIATRICS CORP.HXW2026-08-21
00840536822901Response SpineORTHOPEDIATRICS CORP.HXW2026-08-21
10705034579627N/AMedos International SàrlHXW2026-08-14
10705034579634N/AMedos International SàrlHXW2026-08-14
00840606191654Overwatch PCFSPINAL ELEMENTS, INC.HXW2026-07-31
00840606191661Overwatch PCFSPINAL ELEMENTS, INC.HXW2026-07-31
00840606191760Overwatch PCFSPINAL ELEMENTS, INC.HXW2026-07-31
B8034709150ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709160ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709170ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709180ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709190ORTHOMEDORTHO-MED, INC.HXW2026-07-14
008401944958133P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958203P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958373P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958443P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958513P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
08800089476886Surgical InstrumentJeil Medical CorporationHXW2026-04-09
08800089476893Surgical InstrumentJeil Medical CorporationHXW2026-04-09
07640332475553CURE 2.0 ACPSpineArt SAHXW2025-11-12
07640375234834PERLA ® TLSpineArt SAHXW2025-11-10
07640375234841PERLA ® TLSpineArt SAHXW2025-11-10
07640375234858PERLA ® TLSpineArt SAHXW2025-11-10
07640375234865PERLA ® TLSpineArt SAHXW2025-11-10
08809695601781GSS™ and AnyPlus®GS Medical Co., Ltd.HXW2025-03-17
08809695630187GSS™ and AnyPlus®GS Medical Co., Ltd.HXW2025-03-17
08809885726928Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17