BioRestore BRS-2111
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
by Inion Oy
Identity
- Trade Name
- Inion GTR™ BioRestore EUDAMEDInion GTR BioRestore™ FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Inion BioRestore EUDAMEDMorsels 1.5 cc FDA UDI
- Model / Reference
- BRS-2111 EUDAMEDBRS-2108 EUDAMEDBRS-2110 EUDAMED1 FDA UDI
- Description
- Morsels 1.5 cc FDA UDI
Identifiers
- Catalog Number
- BRS-2110 FDA UDI
- Primary DI / UDI-DI
- 06438408009235 EUDAMED06438408009211 EUDAMED06438408009686 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408009235 EUDAMEDB-06438408009211 EUDAMEDB-06438408009686 EUDAMED
- 510(k) Number
- K070784 FDA UDI
- FDA Product Code
- LYC FDA UDI
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
BioRestore BRS-2111 is a synthetic bone graft substitute classified under nomenclature code P900402, designed for bone regeneration. Composed of degradable bioactive glass, it promotes osteoconductivity and osteostimulation by forming a silica gel and calcium phosphate layer upon contact with bodily fluids, facilitating new bone tissue formation.
This implantable, sterile, single-use device is supplied as a Class III medical device under FDA 510(k) and MDD authorizations. It is intended for surgical use in orthopedic applications and must be stored according to manufacturer guidelines to maintain sterility. The device carries a unique UDI (B-06438408009235) for traceability and compliance.
Frequently asked questions
What is the primary material composition of the Inion GTR™ BioRestore and how does it support bone regeneration?
The Inion GTR™ BioRestore (BRS-2111) is made from degradable bioactive glass, which promotes bone regeneration through osteoconductivity and osteostimulation. When exposed to bodily fluids, it forms a silica gel and calcium phosphate layer, creating a favorable environment for new bone tissue formation.
Is the Inion GTR™ BioRestore reusable, and what are the implications for its use in clinical settings?
No, the Inion GTR™ BioRestore is explicitly designed as a single-use device, as indicated by the 'REUSABLE: 0' specification. This means each package must be discarded after one surgical procedure to maintain sterility and compliance with medical device regulations.
How should the Inion GTR™ BioRestore be stored to ensure sterility and proper functionality?
The device is sterile and must be stored according to the manufacturer’s guidelines to preserve sterility. Since it is implantable and single-use, adherence to these instructions is critical to prevent contamination and ensure safe surgical use.
What unique identifiers are associated with the Inion GTR™ BioRestore for traceability and regulatory compliance?
The device carries a unique Basic UDI (B-06438408009235) and associated UDI data (ULID: 01FQE2NSRAV6M2VWMJW0FVXC2P, UUID: 33da8891-e549-4be6-9338-6add88c108ae) for traceability and compliance. These identifiers help track the device throughout its lifecycle, ensuring regulatory adherence.
What classification does the Inion GTR™ BioRestore fall under, and what does this mean for its regulatory pathway?
The Inion GTR™ BioRestore is classified as a Class III medical device under FDA 510(k) and MDD authorizations, which means it undergoes stringent regulatory scrutiny due to its implantable nature and potential risk. This classification ensures higher safety standards are met before market authorization.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Inion - Products - BioRestore™ Synthetic Bone Graft Substitute, Inion GTR BioRestore™ - BEUDAMED, Synthetic bone substitute - BioRestore™ - Inion - for orthopedic ..., RevMed Marketplace | Connecting the Dots
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070998 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K070784 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K191764 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-06438408009235 | Class III | Active |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (5)
- EUDAMED b182ed40-d62a-4164-ae7a-4618ad59325f 61 fields · synced Sep 18, 2026
- EUDAMED c36698fa-636f-49c4-9122-5fdc713c6494 61 fields · synced May 18, 2026
- EUDAMED b395e5a1-cce6-4b77-b153-94364d0a7efc 61 fields · synced May 18, 2026
- FDA UDI 67b56898-c9c9-4c32-9972-2b6d3c52c162 35 fields · synced May 30, 2026
- FDA 510(k) K070998 1 fields · synced May 18, 2026