FDA.report

CADENCE®

Primary DI
10381780527169
Company
Ascension Orthopedics, Inc.
Model
10208211
Catalog number
10208211
Device description
Cadence®Total Ankle System, Flat Cut Talar Dome, Size 1, 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
false
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
10381780527169PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
10381780527169PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2Orthopedic888.3110YEligible

Premarket Submissions

SubmissionSupplement
K201507000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K201507000Cadence Total Ankle SystemIntegra LifeSciences Corporation2020-06-29HSN

GMDN Terms

TermDefinition
Fixed-bearing total ankle prosthesisA sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is attached or moulded to one of the components. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement.

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

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