FDA.reportPublic FDA data

FusionMAX Spine Table

Primary DI
00840343716424
Brand
FusionMAX Spine Table
Company
SURGIX MEDICAL LLC
Model
33501
Device description
The FusionMAX™ Table is a mobile surgery table designed for temporary support (
Published
2023-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEATable, Surgical With Orthopedic Accessories, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEATable, Surgical With Orthopedic Accessories, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840343716424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343716424008403437164248403437164240840343716424

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic operating table, electromechanicalA mobile, electrically-powered motorized table designed to support a patient and to provide traction for the limb(s)/spine of the patient during orthopaedic surgical procedures. Its surface consists of articulated sections that can be adjusted, and it is often intended to be used with additional patient positioners. It may have x-ray transparent features.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-247-0477info@surgixmedical.com

Regulatory Flags#

DUNS number
080402644
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840343727178GEN2G2N99727G2N997272025-12-11
00840343726898GEN2G2NHX28085G2NHX280852025-09-11
00840343726904GEN2G2NHX29085G2NHX290852025-09-11
00840343726911GEN2G2NHX29045G2NHX290452025-09-11
00840343726928GEN2G2NHX29055G2NHX290552025-09-11
00840343726935GEN2G2NHX29065G2NHX290652025-09-11
00840343726942GEN2G2G21340G2G213402025-09-11
00840343726621GEN2G2N11074G2N110742025-08-05
00840343726645GEN233501-41-00033501-41-0002025-08-05
00840343726652GEN2G2G36083 G2G36083 2025-08-05
00840343726669GEN2G2N81430G2N81430 2025-08-05
00840343726676GEN2G2N81420G2N81420 2025-08-05
00840343726683GEN2G2N81431G2N814312025-08-05
00840343726690GEN2G2N81421G2N814212025-08-05
00840343726706GEN2G2N81433G2N814332025-08-05
00840343726713GEN2G2N81423G2N814232025-08-05
00840343726584GEN2G2G12090G2G120902025-07-09
00840343726591GEN2G2N48721TCG2N48721TC2025-07-09
00840343726607GEN2G2N99514G2N995142025-07-09
00840343726614GEN2G2N99515G2N995152025-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948350529786MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdJEA2025-09-22
06948350529823MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdJEA2025-09-22
00840343726645GEN2SURGIX MEDICAL LLCJEA2025-08-05
04719886909722DA Power HookUNITED ORTHOPEDIC CORP.JEA2025-07-14
04719886909739DA Power HookUNITED ORTHOPEDIC CORP.JEA2025-07-14
04719886909746DA Power HookUNITED ORTHOPEDIC CORP.JEA2025-07-14
04719886909753DA Power HookUNITED ORTHOPEDIC CORP.JEA2025-07-14
04719886909760DA Power HookUNITED ORTHOPEDIC CORP.JEA2025-07-14
04719886905434DA Power HookUNITED ORTHOPEDIC CORP.JEA2025-03-05
04046768146853JoystickMAQUET GmbHJEA2025-01-27
04719886901658DA Power HookUNITED ORTHOPEDIC CORP.JEA2024-12-11
04719886901672DA Power HookUNITED ORTHOPEDIC CORP.JEA2024-12-11
04719886901689DA Power HookUNITED ORTHOPEDIC CORP.JEA2024-12-11
04719886901696DA Power HookUNITED ORTHOPEDIC CORP.JEA2024-12-11
00840343723156FusionMAXSURGIX MEDICAL LLCJEA2024-08-19
00842430113727FOOT SUPPORT ASSEMBLYMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2024-03-06
04250435539521DORO® LUCENT iMRI Interface Adaptor IMRISpro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer AusrüstungJEA2023-10-25
00842430101311SPAR,LEG,RIGHT RADIOLUCENT,REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430101328SPAR, LEG, LEFT, RADIOLUCENT, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430101335SPAR ASSEMBLY, RIGHT, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430101342SPAR ASSEMBLY, LEFT, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430103414UPPER ARM SUPPORT & PAD, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430105500Trios/OTS Lateral Extension PadMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430106590Radiolucent Leg Spar RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430106613Hana Radiolucent Leg Spar LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430107498Zentrum ZXT System, EUMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430107504Zentrum ZXT System, JPMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430107511Zentrum ZXT System, USMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430108532TRACTION BOOT & PLATE, SMALL, LT & RTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430108549TRACTION BOOT & PLATE, LARGE, LT & RTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19