FDA.report

APEX 3D Total Ankle Replacement System

Primary DI
00889795059659
Company
PARAGON 28, INC.
Model
P10-100-BL3L-S
Catalog number
P10-100-BL3L-S
Device description
APEX 3D™ Tibia, Arc, Left, Size 3, Long, 3DP
Published
2020-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
042961576
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00889795059659PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00889795059659PrimaryGS10

Product Codes

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

Premarket Submissions

SubmissionSupplement
K192994000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K192994000Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.2020-07-10HSN

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

No records found.

Sterilization Methods

Method

Contacts

No records found.

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