Identity
- Trade Name
- POWEREASE™ Instruments FDA UDI
- Generic Name
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
- Device Name
- CONSOLE 2340000 POWEREASE IPC FDA UDI
- Model / Reference
- 2340000 FDA UDI
- Description
- CONSOLE 2340000 POWEREASE IPC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994907448 FDA UDI
- 510(k) Number
- K111520 FDA UDI
- FDA Product Code
- HWE FDA UDIHBE FDA UDIGWF FDA UDI
- GMDN Term
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI882.4310 FDA UDI882.1870 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone/joint surgical power tool motorized handpiece/set, electric, reusable
POWEREASE™ Instruments by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone/joint surgical power tool motorized handpiece/set, electric, reusable.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 54c986e3-25ba-4b1e-a587-d9bf483e4676 35 fields · synced Jun 6, 2026