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APEX 3D Total Ankle Replacement System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name
APEX 3D Total Ankle Replacement System FDA UDI
Generic Name
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
MAVEN, TOTAL ANKLE, PSI, TALUS BONE MODEL, LEFT FDA UDI
Model / Reference
P10-PSI-L102 FDA UDI
Description
MAVEN, TOTAL ANKLE, PSI, TALUS BONE MODEL, LEFT FDA UDI

Identifiers

Catalog Number
P10-PSI-L102 FDA UDI
Primary DI / UDI-DI
00889795111531 FDA UDI
510(k) Number
K202019 FDA UDI
FDA Product Code
HSN FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3110 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Custom-made orthopaedic/craniofacial surgical guide

APEX 3D Total Ankle Replacement System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made orthopaedic/craniofacial surgical guide.

Cleared under the same submission

K202019 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paragon 28

Sources (1)

  • FDA UDI ee0b223d-6177-4459-aae2-9bdc6d677777 35 fields · synced May 30, 2026