FDA.reportPublic FDA data

Trivicta

Primary DI
00822409123407
Brand
Trivicta
Company
Ortho Development Corporation
Model
513-0001
Device description
Collarless STD Size 1
Published
2025-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822409123407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409123407008224091234078224091234070822409123407

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit hip femur prosthesis, one-pieceA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is one-piece and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(801)553-9991customerservice@odev.com

Regulatory Flags#

DUNS number
876542390
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822409080311N/A228-00312026-05-16
00822409098880N/A853-10512026-05-16
00822409131297N/A853-00722026-05-16
00822409131525N/A267-55052026-05-16
00822409133253N/AC-1857-072026-05-16
00822409133260N/AC-1857-082026-05-16
00822409133277N/AC-1857-092026-05-16
00822409133284N/AC-1857-102026-05-16
00822409133291N/AC-1857-112026-05-16
00822409133307N/AC-1857-122026-05-16
00822409133314N/AC-1857-132026-05-16
00822409133321N/AC-1857-142026-05-16
00822409133338N/AC-1857-162026-05-16
00822409133345N/AC-1857-182026-05-16
00822409133352N/AC-1857-202026-05-16
00822409133369N/AC-1858-072026-05-16
00822409133376N/AC-1858-082026-05-16
00822409133383N/AC-1858-092026-05-16
00822409133390N/AC-1858-102026-05-16
00822409133406N/AC-1858-112026-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843575126801Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126818Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126825Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126832Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126849Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126856Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126863Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126870Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126887Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126894Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126900Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126917Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126924Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126931Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126948Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126955Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126962Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126979Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126986Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128621Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128638Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128645Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128652Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128669Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
07611996142334POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142372POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142396POLARSTEMSmith & Nephew, Inc.MEH2016-09-01
07611996103410POLARSTEMSmith & Nephew, Inc.MEH2016-07-25