Identity
- Trade Name
- FusionMAX Spine Table FDA UDI
- Generic Name
- Orthopaedic operating table, electromechanical FDA UDI
- Device Name
- The FusionMAX™ Table is a mobile surgery table designed for temporary support (<24 hours) and positioning of a patient in a prone, supine, or lateral position. The Table is intended for use during surgical procedures, including radiographic imaging during such procedures. The Table is not intended for use in patient transport. FDA UDI
- Model / Reference
- 33501 FDA UDI
- Description
- The FusionMAX™ Table is a mobile surgery table designed for temporary support (<24 hours) and positioning of a patient in a prone, supine, or lateral position. The Table is intended for use during surgical procedures, including radiographic imaging during such procedures. The Table is not intended for use in patient transport. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840343716424 FDA UDI
- FDA Product Code
- JEA FDA UDI
- GMDN Term
- Orthopaedic operating table, electromechanical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4960 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic operating table, electromechanical
FusionMAX Spine Table by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic operating table, electromechanical.
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- ASSY, BASE & TABLE TOP, ProFx INTL — Mizuho Orthopedic Systems, Inc. · Class I
- TABLE, HANA, 100V JAPAN — Mizuho Orthopedic Systems, Inc. · Class I
- ADVANCED TABLE, OPERATING-ROOM, ELECTRICAL — ADVANCED INSTRUMENTATIONS, INC. · Class I
- ASSY, BASE & TOP, ProFx — Mizuho Orthopedic Systems, Inc. · Class I
- ADVANCED TABLE, OPERATING-ROOM, ELECTRICAL — ADVANCED INSTRUMENTATIONS, INC. · Class I
- TABLE, ProAxis — Mizuho Orthopedic Systems, Inc. · Class I
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
- Surgix Medical Llc
Sources (1)
- FDA UDI 6822d7ae-622b-4b29-9910-292e33b3c9fa 35 fields · synced Jun 1, 2026