Identity
- Trade Name
- 5.5 mm Cannulated Drill Bit, TORQ TNT, 375 mm FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Single-use drill bit EUDAMED5.5 mm Cannulated Drill Bit, TORQ TNT, 375 mm FDA UDI
- Model / Reference
- 501766-0375 EUDAMEDFDA UDI
- Description
- 5.5 mm Cannulated Drill Bit, TORQ TNT, 375 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810055523627 EUDAMEDFDA UDI
- Basic UDI-DI
- 081005552Drillbit2T EUDAMED
- 510(k) Number
- K241504 FDA UDI
- FDA Product Code
- OLO FDA UDIHTW FDA UDI
- EMDN Code
- P091303 ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Joint prosthesis implantation kit, single-use
Single-use drill bit by Si-Bone Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 081005552Drillbit2T | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SI-BONE, Inc.
- EUDAMED SRN
- US-MF-000028624
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED da8ce31e-3946-4549-aaec-9b3c508f0d5c 61 fields · synced Jun 18, 2026
- FDA UDI 5eda51fc-fcd5-4a93-a16a-3723c03c94b2 35 fields · synced May 25, 2026