Anyplus II Spinal Fixation System- 2505-6025

GUDID 08809974869420

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.

GS Medical Co., Ltd.

Metallic spinal interbody fusion cage
Primary Device ID08809974869420
NIH Device Record Keyaa1c36a3-ed8f-4e11-b0d3-c6b7a3907301
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnyplus II Spinal Fixation System-
Version Model Number2505-6025
Catalog Number2505-6025
Company DUNS688385418
Company NameGS Medical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809974869420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809974869420]

Moist Heat or Steam Sterilization


[08809974869420]

Moist Heat or Steam Sterilization


[08809974869420]

Moist Heat or Steam Sterilization


[08809974869420]

Moist Heat or Steam Sterilization


[08809974869420]

Moist Heat or Steam Sterilization


[08809974869420]

Moist Heat or Steam Sterilization


[08809974869420]

Moist Heat or Steam Sterilization


[08809974869420]

Moist Heat or Steam Sterilization


[08809974869420]

Moist Heat or Steam Sterilization


[08809974869420]

Moist Heat or Steam Sterilization


[08809974869420]

Moist Heat or Steam Sterilization


[08809974869420]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-26
Device Publish Date2025-12-18

On-Brand Devices [Anyplus II Spinal Fixation System-]

08809974869567The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869550The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869543The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869536The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869529The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869512The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869505The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869499The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869482The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869475The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869468The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869451The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869444The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869437The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869420The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974869413The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868225The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868218The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868201The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868195The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868188The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868171The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868164The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868157The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868140The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868133The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868126The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868119The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868102The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868096The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868089The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868072The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868065The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868058The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868041The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868034The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868027The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868010The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974868003The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red
08809974867914The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, red

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.