FDA.report

APEX 3D Total Ankle Replacement System

Primary DI
00889795130648
Company
PARAGON 28, INC.
Model
P10-854-RAD1-5
Catalog number
P10-854-RAD1-5
Device description
Total Ankle Instrument, Right Angle Drill, Ø4.15 Bit
Published
2024-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00889795130648PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00889795130648PrimaryGS10

Product Codes

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

Premarket Submissions

SubmissionSupplement
K210390000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K210390000Apex 3D Total Ankle Replacement SystemParagon 28, Inc.2021-03-06HSN

GMDN Terms

TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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