Identity
- Trade Name
- In2Bones EUDAMEDFDA UDI
- Generic Name
- Orthopaedic surgical distractor, external FDA UDI
- Device Name
- Non-patient-contacting Class I instruments, Non-Active EUDAMEDBONE REDUCTION FORCEPS, POINTED/SERRATED, 5", NON-STERILE FDA UDI
- Model / Reference
- P06 N0651 EUDAMEDFDA UDI
- Description
- BONE REDUCTION FORCEPS, POINTED/SERRATED, 5", NON-STERILE FDA UDI
Identifiers
- Catalog Number
- P06 N0651 FDA UDI
- Primary DI / UDI-DI
- 00810021869445 EUDAMEDFDA UDI
- Basic UDI-DI
- 08101755051447 EUDAMED
- 510(k) Number
- K170518 FDA UDI
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical distractor, external FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
In2Bones by In2Bones, USA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08101755051447 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- In2Bones, USA
- EUDAMED SRN
- US-MF-000023092
- Authorised Representative
- Conmed Europe BV BE-AR-000035662
Sources (2)
- EUDAMED 703532a9-96e6-417a-b174-051168ff6c7a 61 fields · synced May 31, 2026
- FDA UDI 0ef9ccde-fa1f-4ef8-a994-c5fa4441fc27 36 fields · synced May 30, 2026