FDA.reportPublic FDA data

AGILITY

Primary DI
10603295035299
Brand
AGILITY
Company
DEPUY ORTHOPAEDICS, INC.
Model
1404-03-050
Catalog number
140403050
Device description
AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 3 LEFT CEMENTED
Published
2015-09-24
Public version status
Update
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
HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053569000AGILITY LP TOTAL ANKLE PROSTHESISDePuy Orthopaedics, Inc.2006-03-31HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295035299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329503529910603295035299

GMDN Terms#

Term, Definition table
TermDefinition
Coated ankle talus prosthesisA sterile implantable device designed to replace the proximal talus (talar component) as part of a primary ankle joint replacement or prosthesis revision. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
080506581
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295553588ATTUNE2999-67-0282999670282026-08-26
10603295553595ATTUNE2999-67-0292999670292026-08-26
10603295553601ATTUNE2999-67-0302999670302026-08-26
10603295553618ATTUNE2999-67-0312999670312026-08-26
10603295552680ATTUNE2999670062999670062026-05-29
10603295555001ATTUNE2999-67-0492999670492026-05-29
10603295555018ATTUNE2999-67-0502999670502026-05-29
10603295555025ATTUNE2999-67-0512999670512026-05-29
10603295555032ATTUNE2999-67-0522999670522026-05-29
10603295555049ATTUNE2999-67-0532999670532026-05-29
10603295555056ATTUNE2999-67-0542999670542026-05-29
10603295555544ATTUNE2999-67-0842999670842026-05-29
10603295555582ATTUNE2999-67-0852999670852026-05-29
10603295015154DURALOC1220-28-1481220281482015-09-24
10603295015161DURALOC1220-28-1501220281502015-09-24
10603295015178DURALOC1220-28-1521220281522015-09-24
10603295015185DURALOC1220-28-1541220281542015-09-24
10603295015192DURALOC1220-28-1561220281562015-09-24
10603295015208DURALOC1220-28-1581220281582015-09-24
10603295015215DURALOC1220-28-1601220281602015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795150080APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150097APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150103APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150110APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150127APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150134APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151001APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151018APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151025APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151032APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151049APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151056APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151063APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151070APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151087APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151094APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151100APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151117APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151124APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151131APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151148APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151155APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151162APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151179APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151186APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151193APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151209APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151216APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151223APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151230APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12