PolyLock Ankle Plates AK-UP-9013

GUDID 00840124505704

Utility Straight Plate Revision 13 Hole

FUSION ORTHOPEDICS, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID00840124505704
NIH Device Record Key76cf777e-0004-41e2-802d-70bc5e553150
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolyLock Ankle Plates
Version Model NumberAK-UP-9013
Catalog NumberAK-UP-9013
Company DUNS080307067
Company NameFUSION ORTHOPEDICS, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840124505704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


[00840124505704]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-31
Device Publish Date2022-01-21

On-Brand Devices [PolyLock Ankle Plates]

00840124505889Lateral Fibula Plate Anatomical Right 11 Hole
00840124505872Lateral Fibula Plate Anatomical Right 10 Hole
00840124505865Lateral Fibula Plate Anatomical Right 9 Hole
00840124505858Lateral Fibula Plate Anatomical Right 8 Hole
00840124505483Utility Straight Plate 6 Hole
00840124505476Utility Straight Plate 5 Hole
00840124505469Utility Straight Plate 4 Hole
00840124505452Utility Straight Plate 3 Hole
00840124505445Posterior Lateral Tibia Plate Right 8 Hole
00840124505438Posterior Lateral Tibia Plate Right 7 Hole
00840124505421Posterior Lateral Tibia Plate Right 6 Hole
00840124505414Posterior Lateral Tibia Plate Right 5 Hole
00840124505407Posterior Lateral Tibia Plate Left 8 Hole
00840124505391Posterior Lateral Tibia Plate Left 7 Hole
00840124505384Posterior Lateral Tibia Plate Left 6 Hole
00840124505377Posterior Lateral Tibia Plate Left 5 Hole
00840124505360Posterior Fibula Plate Anatomical Right 11 Hole
00840124505353Posterior Fibula Plate Anatomical Right 10 Hole
00840124505346Posterior Fibula Plate Anatomical Right 9 Hole
00840124505339Posterior Fibula Plate Anatomical Right 8 Hole
00840124505322Posterior Fibula Plate Anatomical Left 11 Hole
00840124505315Posterior Fibula Plate Anatomical Left 10 Hole
00840124505308Posterior Fibula Plate Anatomical Left 9 Hole
00840124505292Posterior Fibula Plate Anatomical Left 8 Hole
00840124505285Medial Malleolus Plate 9 Hole
00840124505278Medial Malleolus Plate 8 Hole
00840124505261Medial Malleolus Plate 7 Hole
00840124505254Lateral Fibula Plate Universal 13 Hole
00840124505247Lateral Fibula Plate Universal 11 Hole
00840124505230Lateral Fibula Plate Universal 9 Hole
00840124505223Lateral Fibula Hook Plate Small
00840124505216Lateral Fibula Plate Anatomical Left 11 Hole
00840124505209Lateral Fibula Plate Anatomical, Left 10 Hole
00840124505193Lateral Fibula Plate Anatomical, Left 9 Hole
00840124505186Lateral Fibula Plate Anatomical, Left 8 Hole
00840124505681Utility Straight Plate Revision 11 Hole
00840124505674Utility Straight Plate Revision 10 Hole
00840124505667Utility Straight Plate Revision 9 Hole
00840124505650Utility Straight Plate Revision 8 Hole
00840124505643AK-UP-9007
00840124505636Utility Straight Plate Revision 6 Hole
00840124505629Utility Straight Plate Revision 5 Hole
00840124505612Utility Straight Plate Revision 4 Hole
00840124505605Utility Straight Plate Revision 3 Hole
00840124505582Utility Straight Plate 16 Hole
00840124505575AK-UP-0015
00840124505568Utility Straight Plate 14 Hole
00840124505551Utility Straight Plate 13 Hole
00840124505544Utility Straight Plate 12 Hole
00840124505537Utility Straight Plate 11 Hole

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.