Identity
- Trade Name
- SafeOp 3 FDA UDI
- Generic Name
- Neurophysiologic monitoring system FDA UDI
- Device Name
- Patient Interface Power Supply FDA UDI
- Model / Reference
- AIX11241 FDA UDI
- Description
- Patient Interface Power Supply FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190376530024 FDA UDI
- 510(k) Number
- K234092 FDA UDI
- FDA Product Code
- ETN FDA UDIGWF FDA UDIGXZ FDA UDIIKN FDA UDIPDQ FDA UDIGXY FDA UDI
- GMDN Term
- Neurophysiologic monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1820 FDA UDI882.1870 FDA UDI882.1350 FDA UDI890.1375 FDA UDI882.1320 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
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
Category: Neurophysiologic monitoring system
SafeOp 3 by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurophysiologic monitoring system.
- Guidance — Nuvasive, Inc. · Class II
- Cadwell Guardian — Cadwell Industries, Inc. · Class II
- Neuromaster — Nihon Kohden Corp. · Class II
- NVM5 — Nuvasive, Inc. · Class II
- BIS — Covidien LP · Class II
- Resident Expert Software Module — FHC, INC. · Class II
- NVM5 — Nuvasive, Inc. · Class II
- NVM5 — Nuvasive, Inc. · Class II
Cleared under the same submission
K234092 also covers:
- SafeOp 3 — ALPHATEC SPINE, INC.
- SafeOp 3 — ALPHATEC SPINE, INC.
- SafeOp 3 — ALPHATEC SPINE, INC.
- SafeOp 3 — ALPHATEC SPINE, INC.
- SafeOp 3 — ALPHATEC SPINE, INC.
- SafeOp 3 — ALPHATEC SPINE, INC.
- SafeOp 3 — ALPHATEC SPINE, INC.
- SafeOp 3 — ALPHATEC SPINE, INC.
- SafeOp 3 — ALPHATEC SPINE, INC.
- SafeOp 3 — ALPHATEC SPINE, INC.
- SafeOp 3 — ALPHATEC SPINE, INC.
- SafeOp 3 — ALPHATEC SPINE, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI 6271a696-6376-4ee9-b592-ba1cd37472fa 35 fields · synced Jun 8, 2026