FDA.reportPublic FDA data

Salto Talaris Total Ankle Prosthesis

Primary DI
00885556832417
Brand
Salto Talaris Total Ankle Prosthesis
Company
Smith & Nephew, Inc.
Model
LJV529T
Catalog number
LJV529T
Device description
SET OF 12 PINS + 1 REAMER
Published
2023-08-02
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
HTOREAMER
LHXTrousers, anti-shock

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1
LHXTrousers, Anti-ShockCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556832417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556832417008855568324178855568324170885556832417

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010482280CLEAR-TRAC721012172101212015-10-22
03596010532619NA721071972107192015-08-30
03596010505132SCULPTOR721069772106972015-08-30
03596010505149SCULPTOR721069672106962015-08-30
03596010505170SCULPTOR721069572106952015-08-30
03596010505194SCULPTOR721070072107002015-08-30
00885554016703560P72202351722023512015-08-29
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
00810112598537DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598544DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598551DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598568DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598575DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598599DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598605DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598612DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598629DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598636DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112592269TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592276TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592283TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592290TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592306TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592313TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592320TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592337TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592344TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592351TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592368TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592375TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592382TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592399TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00850310006434CrossTIE™ Reamer 2.2mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006441CrossTIE™ Reamer 2.5mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006458CrossTIE™ Reamer 2.7mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006465CrossTIE™ Reamer 3.0mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00815432028641MotoBAND CP Reamer, 2.0mmCROSSROADS EXTREMITY SYSTEMSHTO2022-11-30