Anyplus II Spinal Fixation System

Primary DI
08809974858516
Brand
Anyplus II Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
2504-0065
Catalog number
2504-0065
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
08809974858516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809974858516088099748585168809974858516

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
08809974858424Anyplus II Spinal Fixation System2504-00002504-00002025-12-19
08809974858431Anyplus II Spinal Fixation System2504-00252504-00252025-12-19
08809974858448Anyplus II Spinal Fixation System2504-00302504-00302025-12-19
08809974858455Anyplus II Spinal Fixation System2504-00352504-00352025-12-19
08809974858462Anyplus II Spinal Fixation System2504-00402504-00402025-12-19
08809974858479Anyplus II Spinal Fixation System2504-00452504-00452025-12-19
08809974858486Anyplus II Spinal Fixation System2504-00502504-00502025-12-19
08809974858493Anyplus II Spinal Fixation System2504-00552504-00552025-12-19
08809974858509Anyplus II Spinal Fixation System2504-00602504-00602025-12-19
08809974858523Anyplus II Spinal Fixation System2504-00702504-00702025-12-19
08809974858530Anyplus II Spinal Fixation System2504-00752504-00752025-12-19
08809974858547Anyplus II Spinal Fixation System2504-00802504-00802025-12-19
08809974858554Anyplus II Spinal Fixation System2504-00852504-00852025-12-19
08809974858561Anyplus II Spinal Fixation System2504-00902504-00902025-12-19
08809974858578Anyplus II Spinal Fixation System2504-00952504-00952025-12-19
08809974858585Anyplus II Spinal Fixation System2504-05002504-05002025-12-19
08809974858592Anyplus II Spinal Fixation System2504-05252504-05252025-12-19
08809974858608Anyplus II Spinal Fixation System2504-05302504-05302025-12-19
08809974858615Anyplus II Spinal Fixation System2504-05352504-05352025-12-19
08809974858622Anyplus II Spinal Fixation System2504-05402504-05402025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809974858424Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858431Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858448Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858455Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858462Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858479Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858486Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858493Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858509Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858523Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858530Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858547Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858554Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858561Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858578Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858585Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858592Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858608Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858615Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858622Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858639Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858646Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858653Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858660Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858677Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858684Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858691Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858707Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858714Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858721Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19