FDA.reportPublic FDA data

Anyplus II Spinal Fixation System

Primary DI
08809885720018
Brand
Anyplus II Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
GS120-0310
Catalog number
GS120-0310
Device description
Anyplus II Probe, Curved
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
HXBProbe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809885720018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809885720018088098857200188809885720018

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
08800322775561Sheathe BladeGS152-1001GS152-10012026-09-18
08800322775578Sheathe BladeGS152-1002GS152-10022026-09-18
08800322775585Sheathe BladeGS152-1003GS152-10032026-09-18
08800322775592Sheathe BladeGS152-1004GS152-10042026-09-18
08800322775608Sheathe BladeGS152-1005GS152-10052026-09-18
08800322775615Sheathe BladeGS152-1006GS152-10062026-09-18
08800322775622Sheathe BladeGS152-1007GS152-10072026-09-18
08800322775639Sheathe BladeGS152-1008GS152-10082026-09-18
08800322775646Sheathe BladeGS152-1101GS152-11012026-09-18
08800322775653Sheathe BladeGS152-1102GS152-11022026-09-18
08800322775660Sheathe BladeGS152-1103GS152-11032026-09-18
08800322775677Sheathe BladeGS152-1104GS152-11042026-09-18
08800322775684Sheathe BladeGS152-1105GS152-11052026-09-18
08800322775691Sheathe BladeGS152-1106GS152-11062026-09-18
08800322775707Sheathe BladeGS152-1107GS152-11072026-09-18
08800322775714Sheathe BladeGS152-1108GS152-11082026-09-18
08800322776391QUASAR Standalone ACIF System6008-00056008-00052026-09-18
08800322776407QUASAR Standalone ACIF System6008-00066008-00062026-09-18
08800322776414QUASAR Standalone ACIF System6008-00076008-00072026-09-18
08800322776421QUASAR Standalone ACIF System6008-00086008-00082026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088713558PRINCETONPrinceton Medical Group, Inc.HXB2026-08-14
B382SD9213821020Surgical DirectSurgical Direct, Inc.HXB2026-08-07
B382SD483800190Surgical DirectSurgical Direct, Inc.HXB2026-08-03
B382SD4838920Surgical DirectSurgical Direct, Inc.HXB2026-08-03
00840606191593Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191869Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191876Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840183532383BR Surgical, LLCBR Surgical, LLCHXB2026-07-21
18257200046706FIREBIRD SFS,SPECIAL PRODUCTSOrthofix US LLCHXB2026-07-17
05060267134554FORCECORD Passing ProbeXIROS LTDHXB2026-07-06
06974940307830endophixSuzhou Endophix Co., Ltd.HXB2026-06-23
04052536218073uCentumUlrich GmbH & Co. KGHXB2026-06-09
04052536218080uCentumUlrich GmbH & Co. KGHXB2026-06-09
00199150080304Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-06-05
00846338005474ProbeELLIQUENCE, LLCHXB2026-06-01
04052536085507neon3Ulrich GmbH & Co. KGHXB2026-05-28
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800322758151Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800322758168Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800017271095BENCOXCorentec Co., LtdHXB2026-04-10
10649111181665Sklar InstrumentsSKLAR CORPORATIONHXB2025-05-29
08809885720001Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXB2025-03-17
07640177820631Neo Medical Pedicle Screw SystemNeo Medical SAHXB2023-01-26
07898506815241QuinelatoSchobell Industrial LtdaHXB2023-01-09
07899798204461SchobellSchobell Industrial LtdaHXB2022-12-16
G079C5020010040Golden Isles Pedicle Screw SystemIntelivation, LLCHXB2022-10-26
00887482053188Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HXB2022-08-25
10649111296673SklarSKLAR CORPORATIONHXB2019-03-19
10649111296932SklarSKLAR CORPORATIONHXB2019-03-19
10649111297120SklarSKLAR CORPORATIONHXB2019-03-19