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Os2®-Vp
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref T40 SP126Ref T40 SP190
by In2Bones SAS
Identity
- Trade Name
- OS2®-VP EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- OS2-VP VARISATION STAPLE KIT EUDAMEDOS2-VP VARISATION STAPLE KIT INTERAXIS 9 MM 26° FDA UDIOS2-VP VARISATION STAPLE KIT INTERAXIS 9 MM 90° FDA UDI
- Model / Reference
- T40 SP126 EUDAMEDFDA UDIT40 SP190 EUDAMEDFDA UDI
- Description
- OS2-VP VARISATION STAPLE KIT INTERAXIS 9 MM 26° FDA UDIOS2-VP VARISATION STAPLE KIT INTERAXIS 9 MM 90° FDA UDI
Identifiers
- Catalog Number
- T40 SP126 FDA UDIT40 SP190 FDA UDI
- Primary DI / UDI-DI
- 03760225715147 EUDAMEDFDA UDI03760225715154 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225715147 EUDAMEDB-03760225715154 EUDAMED
- 510(k) Number
- K153770 FDA UDI
- FDA Product Code
- JDR FDA UDI
- EMDN Code
- P09120101 OSTEOSYNTHESIS STAPLES EUDAMED
- GMDN Term
- Orthopaedic bone staple, non-adjustable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Angle — 26 degree FDA UDIAngle — 90 degree FDA UDI
Os2®-Vp by In2Bones SAS — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760225715147 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (6)
- EUDAMED d5eac845-3cb2-4871-9e9d-581ad6e6bb06 61 fields · synced Jul 21, 2026
- EUDAMED b22a571a-7737-4b4f-a67a-192bbd6cde2f 61 fields · synced May 16, 2026
- FDA UDI 32f2137f-ad3d-43fa-b406-7d7adf3df919 38 fields · synced May 30, 2026
- FDA UDI bcbe1854-aa1b-4b13-8886-4375404d29a9 38 fields · synced May 30, 2026
- EUDAMED e6cda8ef-9e28-4141-94c6-372f04c81eab 61 fields · synced Jul 9, 2026
- EUDAMED afd87cc2-fd6b-4473-9e82-d9c981f6f70f 61 fields · synced Jul 21, 2026