FDA.report

CADENCE®

Primary DI
10381780527268
Company
Ascension Orthopedics, Inc.
Model
10200115
Catalog number
10200115
Device description
Cadence®Total Ankle System, Flat Cut Talar Trial, Size 5, Right
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
10381780527268PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
10381780527268PrimaryGS10

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

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