Identity
- Trade Name
- SafeOp 3 FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- SO3 Dual Surface Electrode 6-pack FDA UDI
- Model / Reference
- 880-3006 FDA UDI
- Description
- SO3 Dual Surface Electrode 6-pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190376542942 FDA UDI
- 510(k) Number
- K234092 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical non-scalp cutaneous electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Category: Analytical non-scalp cutaneous electrode
SafeOp 3 by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI 9b8203f1-ca70-4bf7-b2d6-6a49d704b90e 35 fields · synced Jun 6, 2026