FDA.report

CADENCE®

Primary DI
10381780527305
Company
Ascension Orthopedics, Inc.
Model
10200213
Catalog number
10200213
Device description
Cadence®Total Ankle System, Flat Cut Talar Trial, Size 3, Left
Published
2020-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
942377524
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
10381780527305PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
10381780527305PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
LHXTrousers, Anti-Shock2Cardiovascular870.5800NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Ankle prosthesis trialA copy of a final prosthesis designed to be used during ankle replacement surgery to determine the correct alignment, size, and fit of the final tibial, talar or bearing prosthesis component. It is one of a set, or a set, of graduated sizes and is typically made of synthetic polymer or metal material. This is a reusable device intended to be sterilized prior to use.

Device Sizes

No records found.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Do Not Use If Package Is Damaged

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Other Devices From This Company

Primary DIBrandModelCatalogPublished
M269IMP89000MT1Movement®IMP-890-00MTIMP-890-00MT2017-09-05
M269IMP89000PP1Movement®IMP-890-00PPIMP-890-00PP2017-09-05
10381780355922Titan™IMP-0926-030-00AIMP-0926-030-00A2018-10-04
10381780355939Titan™IMP-0926-030-01AIMP-0926-030-01A2018-10-04
10381780355946Titan™IMP-0926-030-02AIMP-0926-030-02A2018-10-04
10381780355953Titan™IMP-0926-030-03AIMP-0926-030-03A2018-10-04
10381780355960Titan™IMH-0926-000IMH-0926-0002018-10-04
M268TIWEDGEINSTP1TiWedgeTMTIWEDGEINSTP2016-08-15
M269AW32051CAPTURE™AW-3205AW32052017-08-30
10381780123026CAPTURE™ High Torque Screw SystemCSS500000625WTCSS500000625WT2017-10-09
10381780123033CAPTURE™ High Torque Screw SystemCSS500000630WTCSS500000630WT2017-10-09
10381780123040CAPTURE™ High Torque Screw SystemCSS500000640WTCSS500000640WT2017-10-09
10381780123057CAPTURE™ High Torque Screw SystemCSS500000650WTCSS500000650WT2017-10-09
10381780123064CAPTURE™ High Torque Screw SystemCSS500000670WTCSS500000670WT2017-10-09
M26922286111Integra®222861122286112017-08-30
M26922378111Integra®223781122378112017-08-30
M269AI11031CAPTURE™AI-1103AI11032017-08-30
M269AI31011CAPTURE™AI-3101AI31012017-08-30
M269AI32011CAPTURE™AI-3201AI32012017-08-30
M269AI32021CAPTURE™AI-3202AI32022017-08-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00198506089589ELMED INCORPORATEDELMED INCORPORATEDLHX2026-03-13
00198506089596ELMED INCORPORATEDELMED INCORPORATEDLHX2026-03-13
00885556919620R3Smith & Nephew, Inc.LHX2024-11-06
00885556919613R3Smith & Nephew, Inc.LHX2024-11-04
00191083047300AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047317AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047324AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047331AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047348AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047355AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047362AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047379AlloWedgeRti Surgical, Inc.LHX2024-10-14
00840343722876GEN2SURGIX MEDICAL LLCLHX2024-06-28
08800017205267LOSPA Knee System, EXULT Knee SystemCorentec Co., LtdLHX2024-01-12
08800068981486LOSPA Knee System, EXULT Knee SystemCorentec Co., LtdLHX2024-01-12
00840343720537GEN2SURGIX MEDICAL LLCLHX2023-12-15
00840343720957GEN2SURGIX MEDICAL LLCLHX2023-12-15
10889981321390SpecialsSEASPINE ORTHOPEDICS CORPORATIONLHX2023-12-06
00840343719326Gen2SURGIX MEDICAL LLCLHX2023-11-14
00840343719364Gen2SURGIX MEDICAL LLCLHX2023-11-14
00885556910757LegionSmith & Nephew, Inc.LHX2023-09-06
00840019967655Reform® Ti CT Modular MIS Pedicle Screw SystemPRECISION SPINE, INC.LHX2023-08-07
00885556832417Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LHX2023-08-02
10889981308315SpecialsSEASPINE ORTHOPEDICS CORPORATIONLHX2023-03-24
10889981308322SpecialsSEASPINE ORTHOPEDICS CORPORATIONLHX2023-03-24
10889981308339SpecialsSEASPINE ORTHOPEDICS CORPORATIONLHX2023-03-24
10889981308346SpecialsSEASPINE ORTHOPEDICS CORPORATIONLHX2023-03-24
10889981308353SpecialsSEASPINE ORTHOPEDICS CORPORATIONLHX2023-03-24
10889981308438SpecialsSEASPINE ORTHOPEDICS CORPORATIONLHX2023-03-24
00850005827337GENESIS AWL/TAPPERGenesis Biologics, Inc.LHX2023-03-16