InSpace™ 0131

GUDID 17290013396058

InSpace™ system, Medium The InSpace™ Subacromial Tissue Spacer System is a Shoulder spacer for massive irreparable rotator cuff tears, resorbable, inflatable, non-fixed. The InSpace™ Subacromial Tissue Spacer System implant is designed to act as a spacer, creating a physical barrier between tissues in the subacromial space. It is supplied sterile (EtO) and intended for single use.

ORTHO-SPACE LTD

Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer

• Primary Device ID: 17290013396058
• NIH Device Record Key: 710d4597-8b48-4531-85ab-eb4886687a01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InSpace™
• Version Model Number: 0131
• Catalog Number: 0131
• Company DUNS: 533152083
• Company Name: ORTHO-SPACE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290013396058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200039

FDA Product Code

• QPQ: Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-09
• Device Publish Date: 2021-08-01

On-Brand Devices [InSpace™]

• 17290013396065: InSpace™ system, Large The InSpace™ Subacromial Tissue Spacer System is a Shoulder spacer fo
• 17290013396058: InSpace™ system, Medium The InSpace™ Subacromial Tissue Spacer System is a Shoulder spacer f
• 17290013396041: InSpace™ system Small The InSpace™ Subacromial Tissue Spacer System is a Shoulder spacer for