Identity
- Trade Name
- FusionMAX FDA UDI
- Generic Name
- Operating table patient positioning set, reusable FDA UDI
- Device Name
- FlexFrame- Patient supoort device. Designed to support and position torso in prone position. Two carbon fiber arc plates with removable pads fit into base that is attached to surgical table top. Height adjustable with crank handle. FDA UDI
- Model / Reference
- 33516 FDA UDI
- Description
- FlexFrame- Patient supoort device. Designed to support and position torso in prone position. Two carbon fiber arc plates with removable pads fit into base that is attached to surgical table top. Height adjustable with crank handle. FDA UDI
Identifiers
- Catalog Number
- 33516 FDA UDI
- Primary DI / UDI-DI
- 00840343716714 FDA UDI
- FDA Product Code
- JEA FDA UDI
- GMDN Term
- Operating table patient positioning set, reusable 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 patient positioning set, reusable
FusionMAX by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 eeaef84c-fb67-4ed5-8876-83684969cccf 35 fields · synced Jun 7, 2026