FDA.reportPublic FDA data

AnyPlus Spinal Fixation System

Primary DI
08809885718985
Brand
AnyPlus Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
GS117-1021
Catalog number
GS117-1021
Device description
Hex Male 3.0
Published
2025-07-18
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809885718985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809885718985088098857189858809885718985

GMDN Terms#

Term, Definition table
TermDefinition
Screw-extraction orthopaedic reamer, reusableA surgical tool designed for overdrilling, gripping, and extracting an implanted surgical screw shaft when the screw head has become defective or detached, or the shaft has broken. It is in the form of a thin hollow metal shaft, with saw teeth at the cutting edge and a conical thread within the lumen. The device is rotated around the screw shaft to remove a thin layer of bone, either by a surgical power tool or a manual handle, until the internal thread grips the screw for removal. 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
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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