FDA.report

Lateral Positioner Set

Primary DI
00842430104596
Brand
Lateral Positioner Set
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
7300
Catalog number
7300
Published
2021-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JEATable, Surgical With Orthopedic Accessories, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
JEATable, Surgical With Orthopedic Accessories, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842430104596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430104596008424301045968424301045960842430104596

GMDN Terms

TermDefinition
Operating table torso positionerA preformed device (e.g., cushion, foam pad, lateral post, bolster, wedge, multi-jointed metal structure) designed to be attached to an operating table for stabilizing a patient's body trunk (e.g., shoulders, chest, pelvis, hips) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures (e.g., orthopaedic surgery). It is typically used when the patient is in the prone, lateral, or Trendelenburg position; it may be adhesive or components for attachment to the operating table (e.g., adaptors, straps) may be included with the device. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags

DUNS number
084527241
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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 DIBrandModelCatalogPublished
10842430116749PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
10842430116756PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
00842430109188PRONECONNECT PROTECTIVE HELMETPC501FHPC501FH2025-08-29
00842430109195PRONECONNECT ADJUSTABLE HELMETPC502AHPC502AH2025-08-29
00842430109201PRONECONNECT COMBO PACK 4L, 3M, 3SPC-COMBOPC-COMBO2025-08-29
00842430109218PRONECONNECT LOW PROFILE MIRRORPC520MPC520M2025-08-29
00842430109225PRONECONNECT ADJUSTABLE MIRRORPC590MPC590M2025-08-29
00842430109232PRONECONNECT MIRROR WITH POST HOLESPC580MPC580M2025-08-29
00842430109249PRONECONNECT TRIOS MIRROR PLATFORMPC700MPC700M2025-08-29
00842430109256PRONECONNECT CUSHION INSERT, SINGLE, SPC507EAPC507CS2025-08-29
00842430109263PRONECONNECT CUSHION INSERT, SINGLE, MPC505EAPC505CS2025-08-29
00842430109270PRONECONNECT CUSHION INSERT, SINGLE, LPC503EAPC503CS2025-08-29
00842430109287PRONECONNECT ADJUSTABLE HELMET & MIRRORPC510HMPC510HM2025-08-29
00842430109140ADANTE KNEE PROCEDURE KIT, LEFT6895K-L6895K-L2025-07-28
00842430109157ADANTE KNEE PROCEDURE KIT, RIGHT6895K-R6895K-R2025-07-28
00842430109164ADANTE DAA HIP PROCEDURE KIT, LEFT6895AH-L6895AH-L2025-07-28
00842430109171ADANTE DAA HIP PROCEDURE KIT, RIGHT6895AH-R6895AH-R2025-07-28
00842430116728TRAPEZE ARM ASSEMBLY, PATIENT HELPER3423-053423-052025-07-28
00842430116261KIT, HANA SSXT MAQUET 1140 VERSION687668762023-01-17
10842430111539PKIT, INDIV W/SHEARGARD, SST-3000 (1)5819-158192022-01-05

Other Devices Sharing Product Codes

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