FDA.reportPublic FDA data

GSS™ and AnyPlus®

Primary DI
08809695630187
Brand
GSS™ and AnyPlus®
Company
GS Medical Co., Ltd.
Model
GS110-1532
Catalog number
GS110-1532
Device description
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
08809695630187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809695630187088096956301878809695630187

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
08800104097980Anyplus II Spinal Fixation SystemGS120-1700GS120-17002026-08-18
08800322750834PYXIS 3D Titanium Cage SystemGS138-5814GS138-58142026-08-18
08800322758106PYXIS 3D Titanium Cage SystemGS138-5815GS138-58152026-08-18
08800322758113PYXIS 3D Titanium Cage SystemGS138-5816GS138-58162026-08-18
08800322759516Torque Limiting HandleGS112-0611GS112-06112026-08-18
08800322759523QUASAR Standalone ACIF SystemGS136-8205GS136-82052026-08-18
08800322759530QUASAR Standalone ACIF SystemGS136-8207GS136-82072026-08-18
08800322759547QUASAR Standalone ACIF SystemGS136-8209GS136-82092026-08-18
08800322759554QUASAR Standalone ACIF SystemGS136-8211GS136-82112026-08-18
08800322759561QUASAR Standalone ACIF SystemGS136-8405GS136-84052026-08-18
08800322759578QUASAR Standalone ACIF SystemGS136-8407GS136-84072026-08-18
08800322759585QUASAR Standalone ACIF SystemGS136-8409GS136-84092026-08-18
08800322759592QUASAR Standalone ACIF SystemGS136-8411GS136-84112026-08-18
08806395408481DistractorGS133-1157GS133-11572026-08-18
08809974805459PYXIS 3D Titanium Cage SystemGS132-1008PGS132-1008P2026-08-18
08809974805466PYXIS 3D Titanium Cage SystemGS132-1009PGS132-1009P2026-08-18
08809974805473PYXIS 3D Titanium Cage SystemGS132-1010PGS132-1010P2026-08-18
08809974805480PYXIS 3D Titanium Cage SystemGS132-1012PGS132-1012P2026-08-18
08809974805497PYXIS 3D Titanium Cage SystemGS132-1014PGS132-1014P2026-08-18
08809974805503PYXIS 3D Titanium Cage SystemGS132-1016PGS132-1016P2026-08-18

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
08809885726911Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17
08809885726928Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17