FDA.report

APEX 3D Total Ankle Replacement System

Primary DI
00889795132321
Company
PARAGON 28, INC.
Model
P10-842-35SQ
Catalog number
P10-842-35SQ
Device description
3.5MM Square Tip, 13 CM, Total Ankle Tibia Drill
Published
2024-02-01
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
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00889795132321PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00889795132321PrimaryGS10

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
Cannulated surgical drill bit, single-useA metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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