FDA.reportPublic FDA data

Alliant Biotech

Primary DI
G61122051020550
Brand
Alliant Biotech
Company
MEDISURGE LLC
Model
20x55
Catalog number
22-05-102055
Device description
Symmetric Total Knee Metaphyseal Stem Size 20x55
Published
2024-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080199000SYMMETRIC TOTAL KNEE SYSTEMSignal Medical Corporation2008-07-03JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G61122051020550PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur stem prosthesisA sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8883071144mmorrissey@medisurge.com

Regulatory Flags#

DUNS number
119198202
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G611BIO110210Alliant BiotechBIO-1-1021BIO-1-10212024-08-16
G611BIO110220Alliant BiotechBIO-1-1022BIO-1-10222024-08-16
G611BIO110230Alliant BiotechBIO-1-1023BIO-1-10232024-08-16
G611BIO110240Alliant BiotechBIO-1-1024BIO-1-10242024-08-16
G611BIO11024B0Alliant BiotechBIO-1-1024-BBIO-1-1024-B2024-08-16
G611BIO11024C0Alliant BiotechBIO-1-1024-CBIO-1-1024-C2024-08-16
G611BIO110310Alliant BiotechBIO-1-1031BIO-1-10312024-08-16
G611BIO110320Alliant BiotechBIO-1-1032BIO-1-10322024-08-16
G611BIO110330Alliant BiotechBIO-1-1033BIO-1-10332024-08-16
G611BIO11033R0Alliant BiotechBIO-1-1033-RBIO-1-1033-R2024-08-16
G611BIO110340Alliant BiotechBIO-1-1034BIO-1-10342024-08-16
G611BIO11034R0Alliant BiotechBIO-1-1034-RBIO-1-1034-R2024-08-16
G611BIO110350Alliant BiotechBIO-1-1035BIO-1-10352024-08-16
G611BIO110360Alliant BiotechBIO-1-1036BIO-1-10362024-08-16
G611BIO110370Alliant BiotechBIO-1-1037BIO-1-10372024-08-16
G611BIO110810Alliant BiotechBIO-1-1081BIO-1-10812024-08-16
G611BIO110820Alliant BiotechBIO-1-1082BIO-1-10822024-08-16
G611BIO110830Alliant BiotechBIO-1-1083BIO-1-10832024-08-16
G611BIO110840Alliant BiotechBIO-1-1084BIO-1-10842024-08-16
G611WF110010Alliant Biotech15mm Cancellous Bone ScrewWF-1-10012024-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536705Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536712Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536781Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536798Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
E31442411410SignatureMaterialise NVJWH2026-09-24
E31442422415SignatureMaterialise NVJWH2026-09-24
E31442422450SignatureMaterialise NVJWH2026-09-24
E31442422451SignatureMaterialise NVJWH2026-09-24
E31442422452SignatureMaterialise NVJWH2026-09-24
E31442422453SignatureMaterialise NVJWH2026-09-24
E31442422455SignatureMaterialise NVJWH2026-09-24
E31442422456SignatureMaterialise NVJWH2026-09-24
E31442422457SignatureMaterialise NVJWH2026-09-24
E31442422458SignatureMaterialise NVJWH2026-09-24
E31442422460SignatureMaterialise NVJWH2026-09-24
E31442422461SignatureMaterialise NVJWH2026-09-24
E31442422462SignatureMaterialise NVJWH2026-09-24
E31442422463SignatureMaterialise NVJWH2026-09-24
E31442422465SignatureMaterialise NVJWH2026-09-24
E31442422466SignatureMaterialise NVJWH2026-09-24
E31442422467SignatureMaterialise NVJWH2026-09-24
E31442422468SignatureMaterialise NVJWH2026-09-24