FDA.reportPublic FDA data

N/A

Primary DI
00822409129775
Brand
N/A
Company
Ortho Development Corporation
Model
C-1808-82
Device description
Uni Knee Keeled Tibial Tray Trial Size 8 Right
Published
2024-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211471000Balanced Knee System UniOrtho Development Corporation2021-12-16HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822409129775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409129775008224091297758224091297750822409129775

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trial, reusableA copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)553-9997customerservice@odev.com

Regulatory Flags#

DUNS number
876542390
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822409130153N/A863-12062025-03-17
00822409130160N/A863-12072025-03-17
00822409130177N/A863-12082025-03-17
00822409130184N/A863-12092025-03-17
00822409130191N/A863-12102025-03-17
00822409130207N/A863-12112025-03-17
00822409130214N/A863-22062025-03-17
00822409130221N/A863-22072025-03-17
00822409130238N/A863-22082025-03-17
00822409130245N/A863-22092025-03-17
00822409130252N/A863-22102025-03-17
00822409130269N/A863-22112025-03-17
00822409082124N/A233-01382026-07-16
00822409082131N/A233-01392026-07-16
00822409082148N/A233-01402026-07-16
00822409082155N/A233-01412026-07-16
00822409082162N/A233-01422026-07-16
00822409082179N/A233-01432026-07-16
00822409082186N/A233-01442026-07-16
00822409082193N/A233-01452026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810129550009OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550023OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550030OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550047OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550061OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550078OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550085OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550108OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550115OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550122OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550139OvertureTiOverture Resurfacing IncHSX2026-10-18
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
05404028000922SurgiCase PlannerMaterialise NVHSX2025-05-14
00822409130153N/AOrtho Development CorporationHSX2025-03-17
00822409130160N/AOrtho Development CorporationHSX2025-03-17
00822409130177N/AOrtho Development CorporationHSX2025-03-17
00822409130184N/AOrtho Development CorporationHSX2025-03-17
00822409130191N/AOrtho Development CorporationHSX2025-03-17
00822409130207N/AOrtho Development CorporationHSX2025-03-17
00822409130214N/AOrtho Development CorporationHSX2025-03-17
00822409130221N/AOrtho Development CorporationHSX2025-03-17
00822409130238N/AOrtho Development CorporationHSX2025-03-17
00822409130245N/AOrtho Development CorporationHSX2025-03-17
00822409130252N/AOrtho Development CorporationHSX2025-03-17
00822409130269N/AOrtho Development CorporationHSX2025-03-17
00810129550221OvertureTiOverture Resurfacing IncHSX2024-12-06
00810129550238OvertureTiOverture Resurfacing IncHSX2024-12-06
00810129550245OvertureTiOverture Resurfacing IncHSX2024-12-06
00810129550016OvertureTiOverture Resurfacing IncHSX2023-10-18
00810129550054OvertureTiOverture Resurfacing IncHSX2023-10-18