FDA.reportPublic FDA data

AnyPlus Spinal Fixation System

Primary DI
08809885718961
Brand
AnyPlus Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
GS117-1016
Catalog number
GS117-1016
Device description
Hex Female 13.8
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
08809885718961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809885718961088098857189618809885718961

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857615779K2M General InstrumentsVB Spine LLCLXH2026-10-28
M739193990906Non-Modular Convex TrialCAPTIVA SPINE, INC.LXH2026-10-28
M739193996906Non-Modular Lordotic Trial AssemblyCAPTIVA SPINE, INC.LXH2026-10-28
M739243999005SG Implant Driver-SCAPTIVA SPINE, INC.LXH2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28
00810055525164NON NAVIGATED STYLET-OBTURATOR ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525188CANNULATED PROBE IMPACTION CAP ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525195CANNULATED PROBE HANDLE ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525218GRANITE CANNULATED PROBE SHAFTSi-Bone Inc.LXH2026-10-27
00889024702233OsseoFitZimmer, Inc.LXH2026-10-27
00889024702240OsseoFitZimmer, Inc.LXH2026-10-27
00889024702479OsseoFitZimmer, Inc.LXH2026-10-27
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23