InSpace™ 0132

GUDID 17290013396065

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.

ORTHO-SPACE LTD

Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer
Primary Device ID17290013396065
NIH Device Record Key663f3434-3cbe-4299-9436-6cb8363fc154
Commercial Distribution StatusIn Commercial Distribution
Brand NameInSpace™
Version Model Number0132
Catalog Number0132
Company DUNS533152083
Company NameORTHO-SPACE LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS117290013396065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QPQShoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-09
Device Publish Date2021-08-01

On-Brand Devices [InSpace™]

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

Trademark Results [InSpace]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INSPACE
INSPACE
90842184 not registered Live/Pending
Inspace, Inc.
2021-07-22
INSPACE
INSPACE
90689417 not registered Live/Pending
InSpace Proximity, Inc.
2021-05-04
INSPACE
INSPACE
86275958 4856367 Live/Registered
Ortho-Space Ltd
2014-05-08
INSPACE
INSPACE
85082988 not registered Dead/Abandoned
Ortho-Space Ltd
2010-07-13
INSPACE
INSPACE
76110305 2657909 Dead/Cancelled
Infinite Space Systems, Inc.
2000-08-16
INSPACE
INSPACE
73309989 1206485 Dead/Cancelled
International Space Risk Management Systems
1981-05-12

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