FDA.reportPublic FDA data

Alliant Biotech

Primary DI
G611WZ110420
Brand
Alliant Biotech
Company
MEDISURGE LLC
Model
Size 2x8
Catalog number
WZ-1-1042
Device description
Unicompartmental Tibial Poly Size 2 8mm
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
G611WZ110420PrimaryHIBCC0

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
00192629475007EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475014EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475021EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475038EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475045EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475052EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475069EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475076EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475083EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475090EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475106EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475113EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475120EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475137EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475144EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475151EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475168EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475175EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475182EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475199EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475205EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475212EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475229EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475236EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475243EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475250EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475267EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475274EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475281EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475298EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03