The JASPER Spinal Fixation System60

GUDID 08800044765208

GBS Commonwealth Co.,Ltd.

Bone-screw internal spinal fixation system rod

• Primary Device ID: 08800044765208
• NIH Device Record Key: bb103a27-6e7b-42b1-90f6-e4de293f935d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The JASPER Spinal Fixation System60
• Version Model Number: L252-55105
• 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	08800044765208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190762

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

[08800044765208]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-12-25
• Device Publish Date: 2019-11-20

On-Brand Devices [The JASPER Spinal Fixation System60]

• 08800044753304: L24F-0095
• 08800044753298: L24F-0090
• 08800044753281: L24F-0085
• 08800044753274: L24F-0080
• 08800044753267: L24F-0075
• 08800044753250: L24F-0070
• 08800044753243: L24F-0065
• 08800044753236: L24F-0060
• 08800044753229: L24F-0055
• 08800044753212: L24F-0050
• 08800044753205: L24F-0045
• 08800044753199: L24F-0040
• 08800044753182: L24F-0035
• 08800044753175: L24F-0030
• 08800044753168: L24F-95120
• 08800044753151: L24F-95115
• 08800044753144: L24F-95110
• 08800044753137: L24F-95105
• 08800044753120: L24F-95100
• 08800044753113: L24F-9595
• 08800044753106: L24F-9590
• 08800044753090: L24F-9585
• 08800044753083: L24F-9580
• 08800044753076: L24F-9575
• 08800044753069: L24F-9570
• 08800044753052: L24F-9565
• 08800044755643: L24H-6580
• 08800044755636: L24H-6575
• 08800044755629: L24H-6570
• 08800044755612: L24H-6565
• 08800044755605: L24H-6560
• 08800044755599: L24H-6555
• 08800044755582: L24H-6550
• 08800044755575: L24H-6545
• 08800044755568: L24H-6540
• 08800044755551: L24H-6535
• 08800044755544: L24H-6530
• 08800044755537: L24H-6060
• 08800044755520: L24H-6055
• 08800044755513: L24H-6050
• 08800044755506: L24H-6045
• 08800044755490: L24H-6040
• 08800044755483: L24H-6035
• 08800044755476: L24H-6030
• 08800044755469: L24H-5560
• 08800044755452: L24H-5555
• 08800044755445: L24H-5550
• 08800044755438: L24H-5545
• 08800044755421: L24H-5540
• 08800044755414: L24H-5535