FDA.reportPublic FDA data

Anyplus II Spinal Fixation System

Primary DI
08809974809563
Brand
Anyplus II Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
2505-9070
Catalog number
2505-9070
Device description
The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, reduction screw, canulated screws, long arm screws, cortical screws, and a set screw). The screws are available with diameters ranging from 4.5 to 10.5mm, and lengths ranging from 20-100mm in 5mm increments. They are available in noncannulated, cannulated, and longarm geometries with both mono and poly types for each geometry option. All AnyPlus II Spinal Fixation System implant components are manufactured from Ti6AI4V ELI according to ASTM F136. These implants are supplied non-sterile and are not reusable. The instruments in this system are supplied non-sterile, are reusable, and patient contacting materials are fabricated from Precipitation Hardened Stainless Steels (STS630 and STS555) that complies with ASTM F899.
Published
2025-12-19
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

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
08809974809563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809974809563088099748095638809974809563

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA 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.

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
false
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
08809974809440Anyplus II Spinal Fixation System2505-95502505-95502025-12-19
08809974809457Anyplus II Spinal Fixation System2505-95452505-95452025-12-19
08809974809464Anyplus II Spinal Fixation System2505-95402505-95402025-12-19
08809974809471Anyplus II Spinal Fixation System2505-95352505-95352025-12-19
08809974809488Anyplus II Spinal Fixation System2505-95302505-95302025-12-19
08809974809495Anyplus II Spinal Fixation System2505-95252505-95252025-12-19
08809974809501Anyplus II Spinal Fixation System2505-95002505-95002025-12-19
08809974809518Anyplus II Spinal Fixation System2505-909522505-90952025-12-19
08809974809525Anyplus II Spinal Fixation System2505-90902505-90902025-12-19
08809974809532Anyplus II Spinal Fixation System2505-90852505-90852025-12-19
08809974809549Anyplus II Spinal Fixation System2505-90802505-90802025-12-19
08809974809556Anyplus II Spinal Fixation System2505-90752505-90752025-12-19
08809974809570Anyplus II Spinal Fixation System2505-90652505-90652025-12-19
08809974809587Anyplus II Spinal Fixation System2505-90602505-90602025-12-19
08809974809594Anyplus II Spinal Fixation System2505-90552505-90552025-12-19
08809974809600Anyplus II Spinal Fixation System2505-90502505-90502025-12-19
08809974809617Anyplus II Spinal Fixation System2505-90452505-90452025-12-19
08809974809624Anyplus II Spinal Fixation System2505-90402505-90402025-12-19
08809974809631Anyplus II Spinal Fixation System2505-90352505-90352025-12-19
08809974809648Anyplus II Spinal Fixation System2505-90302505-90302025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809974809440Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809457Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809464Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809471Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809488Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809495Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809501Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809518Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809525Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809532Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809549Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809556Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809570Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809587Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809594Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809600Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809617Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809624Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809631Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809648Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809655Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809662Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974818879Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974836231Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974836286Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974837856Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974837955Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974839355Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974849590Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974849637Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19