Identity
- Trade Name
- 5MS EUDAMEDFDA UDI
- Generic Name
- Orthopaedic fixation implant alignment tool FDA UDI
- Device Name
- Non-patient-contacting Class I instruments, Non-Active EUDAMEDCOMPRESSION DRILL GUIDE, Ø1.6 & Ø1.9, ASSY FDA UDI
- Model / Reference
- P06 N0581 EUDAMEDFDA UDI
- Description
- COMPRESSION DRILL GUIDE, Ø1.6 & Ø1.9, ASSY FDA UDI
Identifiers
- Catalog Number
- P06 N0581 FDA UDI
- Primary DI / UDI-DI
- 00817906028195 EUDAMEDFDA UDI
- Basic UDI-DI
- 08101755051447 EUDAMED
- 510(k) Number
- K170518 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic fixation implant alignment tool FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Moist Heat or Steam Sterilization FDA UDI
5ms 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 |
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Manufacturer
- Manufacturer
- In2Bones, USA
- EUDAMED SRN
- US-MF-000023092
- Authorised Representative
- Conmed Europe BV BE-AR-000035662
Sources (2)
- EUDAMED 78dc430c-ccc3-4b25-bb32-484e4af8956a 61 fields · synced Jun 8, 2026
- FDA UDI 7138ed05-bd1d-4f84-a6dd-1430d45620e3 36 fields · synced May 30, 2026