GSO GS1 Spacer

GUDID M9935023070

Spacer

GOLD STANDARD ORTHOPEDICS, LLC

Interspinous spinal fixation implant

• Primary Device ID: M9935023070
• NIH Device Record Key: c46f9eae-4a5a-428e-bc79-7bda6b5f2148
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GSO GS1 Spacer
• Version Model Number: 502307
• Company DUNS: 028008203
• Company Name: GOLD STANDARD ORTHOPEDICS, LLC
• 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: false
• 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 Dimensions

• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9935023070 [Primary]

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

[M9935023070]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-07-08

On-Brand Devices [GSO GS1 Spacer]

• M9935023141: Spacer
• M9935023140: Spacer
• M9935023131: Spacer
• M9935023130: Spacer
• M9935023121: Spacer
• M9935023120: Spacer
• M9935023111: Spacer
• M9935023110: Spacer
• M9935023101: Spacer
• M9935023100: Spacer
• M9935023091: Spacer
• M9935023090: Spacer
• M9935023081: Spacer
• M9935023080: Spacerhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLo
• M9935023071: Spacer
• M9935023070: Spacer