Identity
- Trade Name
- POWEREASE™ Instruments FDA UDI
- Generic Name
- Surgical instrument torque limiter FDA UDI
- Device Name
- BREAKOFF 2346010 SET SCREW BREAKOFF FDA UDI
- Model / Reference
- 2346010 FDA UDI
- Description
- BREAKOFF 2346010 SET SCREW BREAKOFF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994917676 FDA UDI
- 510(k) Number
- K111520 FDA UDI
- FDA Product Code
- GWF FDA UDIHBE FDA UDIHWE FDA UDI
- GMDN Term
- Surgical instrument torque limiter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1870 FDA UDI882.4310 FDA UDI878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument torque limiter
POWEREASE™ Instruments by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K111520 also covers:
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI ac424b28-1bd8-40ee-8d5c-1b16e36f76d8 35 fields · synced May 30, 2026