FDA.reportPublic FDA data

MISHA® Knee System, Small, Right

Primary DI
00856047005801
Brand
MISHA® Knee System, Small, Right
Company
Moximed, Inc.
Model
2-1002
Published
2023-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
00856047005801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856047005801008560470058018560470058010856047005801

GMDN Terms#

Term, Definition table
TermDefinition
Implantable knee unloaderA sterile, implantable metallic device intended to reduce the load on the medial compartment of the knee for the treatment of degenerative articular cartilage (e.g., osteoarthritis) without any other alteration to the joint (i.e., no other arthroplasty or prosthesis implant). It typically consists of bases fixed to the medial side of the femoral and tibial condyles, which hold in place a spring-like absorber designed to absorb, redistribute or shift loads on the medial knee compartment. The implant is subcutaneous and extracapsular, and is typically introduced through small skin incisions. It is typically supplied with the required screws and surgical instruments necessary for implantation.

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
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
00856047005894MISHA® Fixation Kit2-30012023-05-05
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
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
00856047005894MISHA® Fixation KitMoximed, Inc.QVV2023-05-05
00856047005900MISHA® Targeting KitMoximed, Inc.QVV2023-05-05
00856047005917MISHA® Torque Limiting DriverMoximed, Inc.QVV2023-05-05