Peridot Anterior Cervical Intervertebral Body Fusion System

GUDID 08800113305076

GBS Commonwealth Co.,Ltd.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08800113305076
• NIH Device Record Key: f5149440-b3b4-4f46-aaf2-09bc069a4c7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peridot Anterior Cervical Intervertebral Body Fusion System
• Version Model Number: C22A-1405
• Company DUNS: 694609156
• Company Name: GBS Commonwealth Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800113305076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202872

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

[08800113305076]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-08
• Device Publish Date: 2021-03-31

On-Brand Devices [Peridot Anterior Cervical Intervertebral Body Fusion System]

• 08800113310551: C24A-1714
• 08800113310544: C24A-1713
• 08800113310537: C24A-1712
• 08800113310520: C24A-1711
• 08800113310513: C24A-1710
• 08800113310506: C24A-1709
• 08800113310490: C24A-1708
• 08800113310483: C24A-1707
• 08800113310476: C24A-1706
• 08800113310469: C24A-1705
• 08800113310452: C24A-1415
• 08800113310445: C24A-1414
• 08800113310438: C24A-1413
• 08800113310421: C24A-1412
• 08800113310414: C24A-1411
• 08800113310407: C24A-1410
• 08800113310391: C24A-1409
• 08800113310384: C24A-1408
• 08800113310377: C24A-1407
• 08800113310360: C24A-1406
• 08800113310353: C24A-1405
• 08800113310346: C24A-1115
• 08800113310339: C24A-1114
• 08800113310322: C24A-1113
• 08800113310315: C24A-1112
• 08800113310308: C24A-1111
• 08800113310292: C24A-1110
• 08800113310285: C24A-1109
• 08800113310278: C24A-1108
• 08800113310261: C24A-1107
• 08800113310254: C24A-1106
• 08800113310247: C24A-1105
• 08800113310230: C247-2015
• 08800113310223: C247-2014
• 08800113310216: C247-2013
• 08800113310209: C247-2012
• 08800113310193: C247-2011
• 08800113310186: C247-2010
• 08800113310179: C247-2009
• 08800113310162: C247-2008
• 08800113310155: C247-2007
• 08800113310148: C247-2006
• 08800113310131: C247-2005
• 08800113310124: C247-1715
• 08800113310117: C247-1714
• 08800113310100: C247-1713
• 08800113310094: C247-1712
• 08800113310087: C247-1711
• 08800113310070: C247-1710
• 08800113310063: C247-1709