The JASPER Spinal Fixation System

GUDID 08800033101888

GBS Commonwealth Co.,Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800033101888
• NIH Device Record Key: 38a05ce2-cd62-4c72-a843-00540106dc44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The JASPER Spinal Fixation System
• Version Model Number: L111-9055
• 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	08800033101888 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173645

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

[08800033101888]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-30

On-Brand Devices [The JASPER Spinal Fixation System]

• 08800033182436: L188-5260
• 08800033182429: L188-5255
• 08800033182412: L188-5250
• 08800033182405: L188-5245
• 08800033182399: L188-5240
• 08800033182382: L188-5235
• 08800033182375: L188-5230
• 08800033182368: L188-5225
• 08800033182351: L188-5220
• 08800033182344: L188-5215
• 08800033182337: L188-5210
• 08800033182320: L188-5160
• 08800033182313: L188-5155
• 08800033182306: L188-5150
• 08800033182290: L188-5145
• 08800033182283: L188-5140
• 08800033182276: L188-5135
• 08800033182269: L188-5130
• 08800033182252: L188-5125
• 08800033182245: L188-5120
• 08800033182238: L188-5115
• 08800033182221: L188-5110
• 08800033182214: L187-5260
• 08800033182207: L187-5255
• 08800033182191: L187-5250
• 08800033182184: L187-5245
• 08800033182177: L187-5240
• 08800033182160: L187-5235
• 08800033182153: L187-5230
• 08800033182146: L187-5225
• 08800033182139: L187-5220
• 08800033182122: L187-5215
• 08800033182115: L187-5210
• 08800033182108: L187-5160
• 08800033182092: L187-5155
• 08800033182085: L187-5150
• 08800033182078: L187-5145
• 08800033182061: L187-5140
• 08800033182054: L187-5135
• 08800033182047: L187-5130
• 08800033182030: L187-5125
• 08800033182023: L187-5120
• 08800033182016: L187-5115
• 08800033182009: L187-5110
• 08800033181996: L186-5260
• 08800033181989: L186-5255
• 08800033181972: L186-5250
• 08800033181965: L186-5245
• 08800033181958: L186-5240
• 08800033181941: L186-5235