InSpace™

Basic Information

• Brand Name: InSpace™
• Primary DI: 17290013396065
• Version / Model: 0132
• Catalog Number: 0132
• Company Name: ORTHO-SPACE LTD
• Labeler DUNS: 533152083
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-01
• Public Version: 1
• Public Version Date: 2021-08-09
• Public Version Status: New
• Public Device Record Key: 663f3434-3cbe-4299-9436-6cb8363fc154

Device Description

InSpace™ system, Large 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QPQ	Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed	Orthopedic	888.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35671	Tendon spacer	An implantable device intended to be used to physically isolate a tendon so that it can function without adhering to adjacent tissue.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290013396065	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN200039	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 29 Degrees Celsius