AnyPlus Spinal Fixation System

Primary DI
08809974819876
Brand
AnyPlus Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
2503-0050
Catalog number
2503-0050
Device description
A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261217000AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.2026-10-02NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809974819876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809974819876088099748198768809974819876

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
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08800322693919VEGA Cervical Screw System1440-0025-M01440-0025-M02026-11-03
08800322693926VEGA Cervical Screw System1440-00301440-00302026-11-03
08800322693933VEGA Cervical Screw System1440-0030-M01440-0030-M02026-11-03
08800322693940VEGA Cervical Screw System1440-00351440-00352026-11-03
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08800322693964VEGA Cervical Screw System1440-00401440-00402026-11-03
08800322693971VEGA Cervical Screw System1440-0040-M01440-0040-M02026-11-03
08800322693988VEGA Cervical Screw System1440-00451440-00452026-11-03
08800322693995VEGA Cervical Screw System1440-0045-M01440-0045-M02026-11-03
08800322694008VEGA Cervical Screw System1440-00501440-00502026-11-03
08800322694015VEGA Cervical Screw System1440-0050-M01440-0050-M02026-11-03
08800322694022VEGA Cervical Screw System1440-00551440-00552026-11-03
08800322694039VEGA Cervical Screw System1440-0055-M01440-0055-M02026-11-03
08800322694046VEGA Cervical Screw System1440-00601440-00602026-11-03
08800322694053VEGA Cervical Screw System1440-0060-M01440-0060-M02026-11-03
08800322694060VEGA Cervical Screw System1440-00651440-00652026-11-03
08800322694077VEGA Cervical Screw System1440-0065-M01440-0065-M02026-11-03
08800322694084VEGA Cervical Screw System1440-00701440-00702026-11-03
08800322694091VEGA Cervical Screw System1440-0070-M01440-0070-M02026-11-03

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