FDA.reportPublic FDA data

Anyplus ll Spinal Fixation System

Primary DI
08800322758199
Brand
Anyplus ll Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
GS120-8545
Catalog number
GS120-8545
Device description
Anyplus II Navigation Tapper Ø4.5
Published
2026-04-21
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
HWXTap, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800322758199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800322758199088003227581998800322758199

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. 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
false
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
08800322708224Anyplus ll Spinal Fixation SystemGS120-2340GS120-23402026-04-21
08800322727270Anyplus ll Spinal Fixation SystemGS120-5500GS120-55002025-10-14
08800322727287Anyplus ll Spinal Fixation SystemGS120-5501GS120-55012025-10-14
08800322727294Anyplus ll Spinal Fixation SystemGS120-5502GS120-55022025-10-14
08800322727300Anyplus ll Spinal Fixation SystemGS120-5503GS120-55032025-10-14
08800322727317Anyplus ll Spinal Fixation SystemGS120-5504GS120-55042025-10-14
08800322727324Anyplus ll Spinal Fixation SystemGS120-5505GS120-55052025-10-14
08800322727331Anyplus ll Spinal Fixation SystemGS120-5506GS120-55062025-10-14
08800322727348Anyplus ll Spinal Fixation SystemGS120-5507GS120-55072025-10-14
08800322727355Anyplus ll Spinal Fixation SystemGS120-5508GS120-55082025-10-14
08800322750001AnyPlus®GS120-1150GS120-11502026-04-21
08800322758120PYXIS 3D Titanium Cervical Cage, CloseGS166-9020GS166-90202026-04-21
08800322758137Anyplus ll Spinal Fixation SystemGS120-8200GS120-82002026-04-21
08800322758144Anyplus ll Spinal Fixation SystemGS120-8210GS120-82102026-04-21
08800322758151Anyplus ll Spinal Fixation SystemGS120-8300GS120-83002026-04-21
08800322758168Anyplus ll Spinal Fixation SystemGS120-8310GS120-83102026-04-21
08800322758175Anyplus ll Spinal Fixation SystemGS120-8900GS120-89002026-04-21
08800322758182Anyplus ll Spinal Fixation SystemGS120-8540GS120-85402026-04-21
08800322758205Anyplus ll Spinal Fixation SystemGS120-8550GS120-85502026-04-21
08800322758212Anyplus ll Spinal Fixation SystemGS120-8555GS120-85552026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120125220280Shark Screw® tapsurgebright GmbHHWX2026-04-30
10705034577913N/AMedos International SàrlHWX2026-04-23
10705034577920N/AMedos International SàrlHWX2026-04-23
10705034577937N/AMedos International SàrlHWX2026-04-23
10705034577944N/AMedos International SàrlHWX2026-04-23
10705034577951N/AMedos International SàrlHWX2026-04-23
10705034577968N/AMedos International SàrlHWX2026-04-23
10705034577975N/AMedos International SàrlHWX2026-04-23
10705034577982N/AMedos International SàrlHWX2026-04-23
10705034577999N/AMedos International SàrlHWX2026-04-23
G079C5020000950Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001000Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001050Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
08800322758182Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758205Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758212Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758229Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758243Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758250Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758281Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758298Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758304Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08809695619663AnyPlus®GS Medical Co., Ltd.HWX2026-04-21
04719962166575Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HWX2025-11-12
04719962166599Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HWX2025-11-12
07640450868374PERLA ®SpineArt SAHWX2025-11-10
07640450868381PERLA ®SpineArt SAHWX2025-11-10
08800308480564INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480571INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480588INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23