FDA.reportPublic FDA data

Anyplus II Spinal Fixation System

Primary DI
08809885726928
Brand
Anyplus II Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
GS120-1540
Catalog number
GS120-1540
Device description
Anyplus II In-Situ Bender, Left
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
08809885726928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809885726928088098857269288809885726928

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
08809974869284Anyplus II Spinal Fixation System2505-05352505-05352025-12-19
08809885799977Anyplus II Spinal Fixation System2502-85402502-85402025-12-18
08809885799984Anyplus II Spinal Fixation System2502-85452502-85452025-12-18
08809885799991Anyplus II Spinal Fixation System2502-85502502-85502025-12-18
08809974779934Anyplus II Spinal Fixation System2502-85552502-85552025-12-18
08809974779941Anyplus II Spinal Fixation System2502-85602502-85602025-12-18
08809974779958Anyplus II Spinal Fixation System2502-85652502-85652025-12-18
08809974779965Anyplus II Spinal Fixation System2502-85702502-85702025-12-18
08809974779972Anyplus II Spinal Fixation System2502-85752502-85752025-12-18
08809974779989Anyplus II Spinal Fixation System2502-85802502-85802025-12-18
08809974779996Anyplus II Spinal Fixation System2502-85852502-85852025-12-18
08809974789957Anyplus II Spinal Fixation System2502-85902502-85902025-12-18
08809974789964Anyplus II Spinal Fixation System2502-85952502-85952025-12-18
08809974789971Anyplus II Spinal Fixation System2502-90002502-90002025-12-18
08809974789988Anyplus II Spinal Fixation System2502-90252502-90252025-12-18
08809974789995Anyplus II Spinal Fixation System2502-90302502-90302025-12-18
08809974799864Anyplus II Spinal Fixation System2502-90352502-90352025-12-18
08809974799871Anyplus II Spinal Fixation System2502-90402502-90402025-12-18
08809974799888Anyplus II Spinal Fixation System2502-90452502-90452025-12-18
08809974799895Anyplus II Spinal Fixation System2502-90502502-90502025-12-18

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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
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B8034709170ORTHOMEDORTHO-MED, INC.HXW2026-07-14
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B8034709190ORTHOMEDORTHO-MED, INC.HXW2026-07-14
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008401944958513P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
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07640375234858PERLA ® TLSpineArt SAHXW2025-11-10
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