Identity
- Trade Name
- FusionMAX FDA UDI
- Generic Name
- Operating table traction frame FDA UDI
- Device Name
- Rope Traction Assembly- metal pulley device designed to be used in cervical spine procedures. To be used in conjunction with rope and surgical weights. Attaches to head of surgical table with mounting assembly FDA UDI
- Model / Reference
- 30427 FDA UDI
- Description
- Rope Traction Assembly- metal pulley device designed to be used in cervical spine procedures. To be used in conjunction with rope and surgical weights. Attaches to head of surgical table with mounting assembly FDA UDI
Identifiers
- Catalog Number
- 30427 FDA UDI
- Primary DI / UDI-DI
- 00840343716776 FDA UDI
- FDA Product Code
- JEA FDA UDI
- GMDN Term
- Operating table traction frame 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
No
FDA UDI
Category: Operating table traction frame
FusionMAX by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Operating table traction frame.
- Arthrex — ALLEN MEDICAL SYSTEMS, INC. · Class I
- Arthrex — ALLEN MEDICAL SYSTEMS, INC. · Class I
- 10MM WELL HIP FIXATION FRAME (6800) — Mizuho Orthopedic Systems, Inc. · Class I
- Arthrex — ALLEN MEDICAL SYSTEMS, INC. · Class I
- 10mm WELL HIP FIXATION FRAME (6850), REFURB — Mizuho Orthopedic Systems, Inc. · Class I
- Arthrex — ALLEN MEDICAL SYSTEMS, INC. · Class I
- 8MM WELL HIP FIXATION FRAME (6800) — Mizuho Orthopedic Systems, Inc. · Class I
- Arthrex — ALLEN MEDICAL 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgix Medical Llc
Sources (1)
- FDA UDI 01c524f6-b777-4554-93c4-1bdc6f8a83dd 35 fields · synced May 30, 2026