PolyLock Ankle TN-AK-4020

GUDID 00840124506046

Ankle Hook Plate Impacting Rod

FUSION ORTHOPEDICS, LLC

Surgical tamp, reusable
Primary Device ID00840124506046
NIH Device Record Keyaa419174-0108-43d1-ab02-890c052a0b60
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolyLock Ankle
Version Model NumberTN-AK-4020
Catalog NumberTN-AK-4020
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
GS100840124506046 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

Moist Heat or Steam Sterilization


[00840124506046]

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]

00840124506466Pointed Tip Reduction Forceps Small
00840124506459Pointed Tip Reduction Forceps Larg
00840124506442Serrated Tip Reduction Forceps Mini
00840124506060Hook Plate Guide Fibula
00840124506053Fibula Hook Guide Drill
00840124506046Ankle Hook Plate Impacting Rod
00840124507098Plate Bending Pliers
00840124508842Lateral Fibula Plate Anatomical, Revision Left 10 Hole
00840124508835Lateral Fibula Plate Anatomical, Revision Left 9 Hole
00840124508828Lateral Fibula Plate Anatomical, Revision Left 8 Hole
00840124508811Utility Straight Plate, Revision 16 Hole
00840124508804Utility Straight Plate, Revision 15 Hole
00840124508798Utility Straight Plate, Revision 14 Hole
00840124508781Utility Straight Plate, Revision 13 Hole
00840124508774Utility Straight Plate, Revision 12 Hole
00840124508767Utility Straight Plate, Revision 11 Hole
00840124508750Utility Straight Plate, Revision 10 Hole
00840124508743Utility Straight Plate, Revision 9 Hole
00840124508736Utility Straight Plate, Revision 8 Hole
00840124508729Utility Straight Plate, Revision 7 Hole
00840124508712Utility Straight Plate, Revision 6 Hole
00840124508705Utility Straight Plate, Revision 5 Hole
00840124508699Utility Straight Plate, Revision 4 Hole
00840124508682Utility Straight Plate, Revision 3 Hole
00840124508675Utility Straight Plate, 16 Hole
00840124508668Utility Straight Plate, 15 Hole
00840124508651Utility Straight Plate, 14 Hole
00840124508644Utility Straight Plate, 13 Hole
00840124508637Utility Straight Plate, 12 Hole
00840124508620Utility Straight Plate, 11 Hole
00840124508613Utility Straight Plate, 10 Hole
00840124508606Utility Straight Plate, 9 Hole
00840124508590Utility Straight Plate, 8 Hole
00840124508583Utility Straight Plate, 7 Hole
00840124508576Utility Straight Plate, 6 Hole
00840124508569Utility Straight Plate, 5 Hole
00840124508552Utility Straight Plate, 4 Hole
00840124508545Utility Straight Plate, 3 Hole
00840124508538Posterior Lateral Tibia Plate, Right 8 Hole
00840124508521Posterior Lateral Tibia Plate, Right 7 Hole
00840124508514Posterior Lateral Tibia Plate, Right 6 Hole
00840124508507Posterior Lateral Tibia Plate, Right 5 Hole
00840124508491Posterior Lateral Tibia Plate, Left 8 Hole
00840124508484Posterior Lateral Tibia Plate, Left 7 Hole
00840124508477Posterior Lateral Tibia Plate, Left 6 Hole
00840124508460Posterior Lateral Tibia Plate, Left 5 Hole
00840124508453Posterior Fibula Plate Anatomical, Right 11 Hole
00840124508446Posterior Fibula Plate Anatomical, Right 10 Hole
00840124508439Posterior Fibula Plate Anatomical, Right 9 Hole
00840124508422Posterior Fibula Plate Anatomical, Right 8 Hole

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