Identity
- Trade Name
- POWEREASE™ Instruments FDA UDI
- Generic Name
- Orthopaedic stereotactic surgery system FDA UDI
- Device Name
- SLEEVE 2343429S 8.0MM NIM SLEEVE FDA UDI
- Model / Reference
- 2343429S FDA UDI
- Description
- SLEEVE 2343429S 8.0MM NIM SLEEVE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994905543 FDA UDI
- 510(k) Number
- K111520 FDA UDI
- FDA Product Code
- HWE FDA UDIHBE FDA UDIGWF FDA UDI
- GMDN Term
- Orthopaedic stereotactic surgery system 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
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: Orthopaedic stereotactic surgery system
POWEREASE™ Instruments by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic stereotactic surgery system.
- TRIGEN — Smith & Nephew, Inc. · Class II
- PULSE — Nuvasive, Inc. · Class II
- KneePlus — PIXEE MEDICAL · Class II
- intellijoint HIP® — Intellijoint Surgical Inc · Class II
- PULSE — Nuvasive, Inc. · Class II
- Navigation Unit Kit — GYDER SURGICAL PTY LTD · Class II
- StealthStation S8 Spine — MEDTRONIC NAVIGATION, INC. · Class II
- WatchTower — Intai Technology Corporation · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 944ee721-7dbb-4212-8b93-2a43067eea12 35 fields · synced Jun 1, 2026