Identity
- Trade Name
- InterOss® EUDAMEDFDA UDI
- Generic Name
- Dental bone matrix implant, animal-derived FDA UDI
- Device Name
- InterOss® EUDAMED
- Model / Reference
- IOLGS150 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852072007148 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00852072007148 EUDAMED
- 510(k) Number
- K151209 FDA UDI
- FDA Product Code
- NPM FDA UDI
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
- GMDN Term
- Dental bone matrix implant, animal-derived FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
InterOss® by Sigmagraft, Inc. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151209 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-00852072007148 | Class III | Active |
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Manufacturer
- Manufacturer
- SigmaGraft Inc.
- EUDAMED SRN
- US-MF-000015980
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 851aa440-75ad-4674-b0ba-4744e3f52bd7 61 fields · synced Jun 20, 2026
- FDA UDI 2619c1e8-4de4-42f9-b205-4c01af0af210 35 fields · synced May 30, 2026
- FDA 510(k) K151209 1 fields · synced May 18, 2026