FDA.reportPublic FDA data

MISHA® Fixation Kit

Primary DI
00856047005894
Brand
MISHA® Fixation Kit
Company
Moximed, Inc.
Model
2-3001
Published
2023-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QVVMedial Knee Implanted Shock Absorber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVVMedial Knee Implanted Shock AbsorberOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220033000MISHA Knee SystemMoximed, Inc.2023-04-10QVV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856047005894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856047005894008560470058948560470058940856047005894

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
808178383
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856047005795MISHA® Knee System, Small, Left2-10012023-05-05
00856047005801MISHA® Knee System, Small, Right2-10022023-05-05
00856047005818MISHA® Knee System, Large, Left2-10032023-05-05
00856047005825MISHA® Knee System, Large, Right2-10042023-05-05
00856047005870MISHA® Trial, Large, Left2-20032023-05-05
00856047005887MISHA® Trial, Large, Right2-20042023-05-05
00856047005832MISHA® Locking Screw, 5.0 x 46 mm, 6-Pack1-30162023-05-05
00856047005849MISHA® Locking Screw, 5.0 x 46 mm, 1-Pack1-30182023-05-05
00856047005856MISHA® Trial, Small, Left2-20012023-05-05
00856047005863MISHA® Trial, Small, Right2-20022023-05-05
00856047005900MISHA® Targeting Kit2-30022023-05-05
00856047005917MISHA® Torque Limiting Driver1-40392023-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856047005795MISHA® Knee System, Small, LeftMoximed, Inc.QVV2023-05-05
00856047005801MISHA® Knee System, Small, RightMoximed, Inc.QVV2023-05-05
00856047005818MISHA® Knee System, Large, LeftMoximed, Inc.QVV2023-05-05
00856047005825MISHA® Knee System, Large, RightMoximed, Inc.QVV2023-05-05
00856047005832MISHA® Locking Screw, 5.0 x 46 mm, 6-PackMoximed, Inc.QVV2023-05-05
00856047005849MISHA® Locking Screw, 5.0 x 46 mm, 1-PackMoximed, Inc.QVV2023-05-05
00856047005856MISHA® Trial, Small, LeftMoximed, Inc.QVV2023-05-05
00856047005863MISHA® Trial, Small, RightMoximed, Inc.QVV2023-05-05
00856047005870MISHA® Trial, Large, LeftMoximed, Inc.QVV2023-05-05
00856047005887MISHA® Trial, Large, RightMoximed, Inc.QVV2023-05-05
00856047005900MISHA® Targeting KitMoximed, Inc.QVV2023-05-05
00856047005917MISHA® Torque Limiting DriverMoximed, Inc.QVV2023-05-05