Identity
- Trade Name
- InSpace™ FDA UDI
- Generic Name
- Tendon spacer FDA UDI
- Device Name
- InSpace™ system Small 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. FDA UDI
- Model / Reference
- 0130 FDA UDI
- Description
- InSpace™ system Small 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. FDA UDI
Identifiers
- Catalog Number
- 0130 FDA UDI
- Primary DI / UDI-DI
- 17290013396041 FDA UDI
- 510(k) Number
- DEN200039 FDA UDI
- FDA Product Code
- QPQ FDA UDI
- GMDN Term
- Tendon spacer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Tendon spacer
InSpace™ by Ortho-Space Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
DEN200039 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ortho-Space Ltd
Sources (1)
- FDA UDI e5f78325-ea39-4d2e-8e3e-69001019a44f 36 fields · synced Jun 6, 2026