APEX 3D Total Ankle Replacement System P10-944-TCR2

GUDID 00889795063694

Talar Recut Guide Posterior Cut

PARAGON 28, INC.

Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable
Primary Device ID00889795063694
NIH Device Record Key6654c324-378c-494c-809c-15746870601b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPEX 3D Total Ankle Replacement System
Version Model NumberP10-944-TCR2
Catalog NumberP10-944-TCR2
Company DUNS042961576
Company NamePARAGON 28, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100889795063694 [Primary]

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


[00889795063694]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-22
Device Publish Date2022-09-14

On-Brand Devices [APEX 3D Total Ankle Replacement System]

00889795099563APEX 3D-PS Total Ankle Replacement System, Talus Impaction Handle, Pad
00889795099051APEX 3D-PS Total Ankle Replacement System, Case Lid
00889795099044APEX 3D-PS Total Ankle Replacement System, Case Base
00889795099013APEX 3D-PS Total Ankle Replacement System, Small Tray
00889795099006APEX 3D-PS Total Ankle Replacement System, Large Instrumentation, Tray
00889795098993APEX 3D-PS Total Ankle Replacement System, Impaction, Tray
00889795098986APEX 3D-PS Total Ankle Replacement System, Talus Trialing, Tray
00889795098979APEX 3D-PS Total Ankle Replacement System, Tibia Trialing, Tray
00889795098962APEX 3D-PS Total Ankle Replacement System, Resection, Tray
00889795098955APEX 3D-PS Total Ankle Replacement System, Alignment, Tray
00889795098931APEX 3D-PS Total Ankle Replacement System, Poly Insertion Tool
00889795097538APEX 3D™ Tibia, Flat, Right, Size 6, Standard, 3DP
00889795097521APEX 3D™ Tibia, Flat, Left, Size 6, Standard, 3DP
00889795097514APEX 3D™ Tibia, Arc, Right, Size 6, Standard, 3DP
00889795097507APEX 3D™ Tibia, Arc, Left, Size 6, Standard, 3DP
00889795076410APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 20MM, NEUTRAL
00889795076397APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 18MM, NEUTRAL
00889795076373APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 16MM, NEUTRAL
00889795076359APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 14MM, NEUTRAL
00889795076335APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 12MM, NEUTRAL
00889795076328APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 11MM, NEUTRAL
00889795076311APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 10MM, NEUTRAL
00889795076304APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 9MM, NEUTRAL
00889795076298APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 8MM, NEUTRAL
00889795076281APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 7MM, NEUTRAL
00889795076274APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 6MM, NEUTRAL
00889795075062APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 20MM, NEUTRAL
00889795075048APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 18MM, NEUTRAL
00889795075024APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 16MM, NEUTRAL
00889795075000APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 14MM, NEUTRAL
00889795074980APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 12MM, NEUTRAL
00889795074973APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 11MM, NEUTRAL
00889795074966APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 10MM, NEUTRAL
00889795074959APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 9MM, NEUTRAL
00889795074942APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 8MM, NEUTRAL
00889795074935APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 7MM, NEUTRAL
00889795074928APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 6MM, NEUTRAL
00889795073716APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 20MM, NEUTRAL
00889795073693APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 18MM, NEUTRAL
00889795073679APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 16MM, NEUTRAL
00889795073655APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 14MM, NEUTRAL
00889795073631APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 12MM, NEUTRAL
00889795073624APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 11MM, NEUTRAL
00889795073617APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 10MM, NEUTRAL
00889795073600APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 9MM, NEUTRAL
00889795073594APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 8MM, NEUTRAL
00889795073587APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 7MM, NEUTRAL
00889795073570APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 6MM, NEUTRAL
00889795072368APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 20MM, NEUTRAL
00889795072344APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 18MM, NEUTRAL

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