ANAX™ OCT SPINAL SYSTEM

GUDID 08800037598516

CG MedTech Co.,Ltd.

Bone-screw internal spinal fixation system rod

• Primary Device ID: 08800037598516
• NIH Device Record Key: 08813d7e-8ec4-43dc-9ea6-180b83bd1c41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANAX™ OCT SPINAL SYSTEM
• Version Model Number: OS2122CR
• Company DUNS: 688811082
• Company Name: CG MedTech Co.,Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800037598516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251725

FDA Product Code

• NKG: Posterior cervical screw system

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

[08800037598516]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-18
• Device Publish Date: 2025-07-10

On-Brand Devices [ANAX™ OCT SPINAL SYSTEM]

• 08800247357194: OS0420
• 08800247357187: OS0410
• 08800037598165: OSS0680
• 08800308480069: OS0240
• 08800308490099: OS2011CR
• 08800308490082: OS2005CR
• 08800308490075: OS2012CC
• 08800308490068: OS2011CC
• 08800308490051: OS2008CC
• 08800308490044: OS2007CC
• 08800308490037: OS2006CC
• 08800308490020: OS2005CC
• 08800308490013: OS2001CC
• 08800037598554: OS2210CR
• 08800037598547: OS2125CR
• 08800037598530: OS2124CR
• 08800037598523: OS2123CR
• 08800037598516: OS2122CR
• 08800037598509: OS2121CR
• 08800037598493: OS2115CR
• 08800037598486: OS2114CR
• 08800037598479: OS2113CR
• 08800037598462: OS2112CR
• 08800037598455: OS2111CR
• 08800037598448: OS2015CR
• 08800037598431: OS2014CR
• 08800037598424: OS2013CR
• 08800037598417: OS2012CR
• 08800037598400: OS2010CR
• 08800037598394: OS2009CR
• 08800037598387: OS2008CR
• 08800037598370: OS2007CR
• 08800037598363: OS2006CR
• 08800037598356: OS2004CR
• 08800037598332: OS2002CR
• 08800037598318: OS2013CC
• 08800037598301: OS2010CC
• 08800037598295: OS2009CC
• 08800037598288: OS2004CC
• 08800037598271: OS2003CC
• 08800037598264: OS2002CC