FDA.reportPublic FDA data

Alliant Biotech

Primary DI
G611WZ110120
Brand
Alliant Biotech
Company
MEDISURGE LLC
Model
Size 2
Catalog number
WZ-1-1012
Device description
Unicompartmental Tibial Tray Size 2
Published
2024-08-16
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
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012800000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012800000SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEMWhiteside Biomechanics, Inc.2002-05-03HRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G611WZ110120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coated unicondylar knee tibia prosthesisA sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device articulates with a femoral component and an insert, and its implantation may be performed with or without bone cement.

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
E31442411410SignatureMaterialise NVHRY2026-09-24
E31442422650SignatureMaterialise NVHRY2026-09-24
E31442422651SignatureMaterialise NVHRY2026-09-24
E31442422652SignatureMaterialise NVHRY2026-09-24
E31442422653SignatureMaterialise NVHRY2026-09-24
E31442422660SignatureMaterialise NVHRY2026-09-24
E31442422661SignatureMaterialise NVHRY2026-09-24
E31442422662SignatureMaterialise NVHRY2026-09-24
E31442422663SignatureMaterialise NVHRY2026-09-24
E31442422670SignatureMaterialise NVHRY2026-09-24
E31442422671SignatureMaterialise NVHRY2026-09-24
E31442422672SignatureMaterialise NVHRY2026-09-24
E31442422673SignatureMaterialise NVHRY2026-09-24
00192629082854EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082861EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082878EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082885EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082892EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082908EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082915EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082922EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082939EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082946EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082953EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082960EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082977EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082984EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082991EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629083004EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629083011EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18