FDA.reportPublic FDA data

Anyplus ll Spinal Fixation System

Primary DI
08809974799796
Brand
Anyplus ll Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
GS110-5057
Catalog number
GS110-5057
Device description
DL Nav Compatible Tap Ø5.5
Published
2025-04-03
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
08809974799796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809974799796088099747997968809974799796

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
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
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08800308479094ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
08800308479117ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
00840606191883Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606191890Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606191906Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195782Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195799Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195805Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195812Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
07290019361343OSSIO® TapOSSIO LTDHWX2026-07-19
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07290019361374OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361381OSSIO® TapOSSIO LTDHWX2026-07-19
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18257200076604CETRAOrthofix US LLCHWX2026-07-17
18257200076611CETRAOrthofix US LLCHWX2026-07-17
18257200076628CETRAOrthofix US LLCHWX2026-07-17
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
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