FDA.reportPublic FDA data

Anyplus II Spinal Fixation System

Primary DI
08800104099878
Brand
Anyplus II Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
GS120-1710
Catalog number
GS120-1710
Device description
Anyplus II Rod Pusher (Straight Type)
Published
2025-03-17
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
08800104099878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800104099878088001040998788800104099878

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. 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
08800322693100VEGA Cervical Screw System0866-10300866-10302026-09-30
08800322693117VEGA Cervical Screw System0866-1030-M00866-1030-M02026-09-30
08800322693124VEGA Cervical Screw System0866-10350866-10352026-09-30
08800322693131VEGA Cervical Screw System0866-1035-M00866-1035-M02026-09-30
08800322693148VEGA Cervical Screw System0866-10400866-10402026-09-30
08800322693155VEGA Cervical Screw System0866-1040-M00866-1040-M02026-09-30
08800322693162VEGA Cervical Screw System0866-10450866-10452026-09-30
08800322693179VEGA Cervical Screw System0866-1045-M00866-1045-M02026-09-30
08800322693186VEGA Cervical Screw System0866-10500866-10502026-09-30
08800322693193VEGA Cervical Screw System0866-1050-M00866-1050-M02026-09-30
08800322693209VEGA Cervical Screw System0866-10550866-10552026-09-30
08800322693216VEGA Cervical Screw System0866-1055-M00866-1055-M02026-09-30
08800322693223VEGA Cervical Screw System0866-10600866-10602026-09-30
08800322693230VEGA Cervical Screw System0866-1060-M00866-1060-M02026-09-30
08800322693247VEGA Cervical Screw System0866-10650866-10652026-09-30
08800322693254VEGA Cervical Screw System0866-1065-M00866-1065-M02026-09-30
08800322693261VEGA Cervical Screw System0866-10700866-10702026-09-30
08800322693278VEGA Cervical Screw System0866-1070-M00866-1070-M02026-09-30
08800322693285VEGA Cervical Screw System0866-10750866-10752026-09-30
08800322693292VEGA Cervical Screw System0866-1075-M00866-1075-M02026-09-30

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Primary DI, Brand, Company table
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00198506095771ELMED INCORPORATEDELMED INCORPORATEDLXH2026-10-09
00198506095788ELMED INCORPORATEDELMED INCORPORATEDLXH2026-10-09
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