Primary Device ID | 00840124508729 |
NIH Device Record Key | ac7dbf6e-cd9b-4029-a6e5-febb9f6dfef8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PolyLock Ankle |
Version Model Number | AK-UP-9007 |
Catalog Number | AK-UP-9007 |
Company DUNS | 080307067 |
Company Name | FUSION ORTHOPEDICS, LLC |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | true |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840124508729 [Primary] |
HRS | Plate, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
[00840124508729]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-04 |
Device Publish Date | 2023-06-26 |
00840124506466 | Pointed Tip Reduction Forceps Small |
00840124506459 | Pointed Tip Reduction Forceps Larg |
00840124506442 | Serrated Tip Reduction Forceps Mini |
00840124506060 | Hook Plate Guide Fibula |
00840124506053 | Fibula Hook Guide Drill |
00840124506046 | Ankle Hook Plate Impacting Rod |
00840124507098 | Plate Bending Pliers |
00840124508842 | Lateral Fibula Plate Anatomical, Revision Left 10 Hole |
00840124508835 | Lateral Fibula Plate Anatomical, Revision Left 9 Hole |
00840124508828 | Lateral Fibula Plate Anatomical, Revision Left 8 Hole |
00840124508811 | Utility Straight Plate, Revision 16 Hole |
00840124508804 | Utility Straight Plate, Revision 15 Hole |
00840124508798 | Utility Straight Plate, Revision 14 Hole |
00840124508781 | Utility Straight Plate, Revision 13 Hole |
00840124508774 | Utility Straight Plate, Revision 12 Hole |
00840124508767 | Utility Straight Plate, Revision 11 Hole |
00840124508750 | Utility Straight Plate, Revision 10 Hole |
00840124508743 | Utility Straight Plate, Revision 9 Hole |
00840124508736 | Utility Straight Plate, Revision 8 Hole |
00840124508729 | Utility Straight Plate, Revision 7 Hole |
00840124508712 | Utility Straight Plate, Revision 6 Hole |
00840124508705 | Utility Straight Plate, Revision 5 Hole |
00840124508699 | Utility Straight Plate, Revision 4 Hole |
00840124508682 | Utility Straight Plate, Revision 3 Hole |
00840124508675 | Utility Straight Plate, 16 Hole |
00840124508668 | Utility Straight Plate, 15 Hole |
00840124508651 | Utility Straight Plate, 14 Hole |
00840124508644 | Utility Straight Plate, 13 Hole |
00840124508637 | Utility Straight Plate, 12 Hole |
00840124508620 | Utility Straight Plate, 11 Hole |
00840124508613 | Utility Straight Plate, 10 Hole |
00840124508606 | Utility Straight Plate, 9 Hole |
00840124508590 | Utility Straight Plate, 8 Hole |
00840124508583 | Utility Straight Plate, 7 Hole |
00840124508576 | Utility Straight Plate, 6 Hole |
00840124508569 | Utility Straight Plate, 5 Hole |
00840124508552 | Utility Straight Plate, 4 Hole |
00840124508545 | Utility Straight Plate, 3 Hole |
00840124508538 | Posterior Lateral Tibia Plate, Right 8 Hole |
00840124508521 | Posterior Lateral Tibia Plate, Right 7 Hole |
00840124508514 | Posterior Lateral Tibia Plate, Right 6 Hole |
00840124508507 | Posterior Lateral Tibia Plate, Right 5 Hole |
00840124508491 | Posterior Lateral Tibia Plate, Left 8 Hole |
00840124508484 | Posterior Lateral Tibia Plate, Left 7 Hole |
00840124508477 | Posterior Lateral Tibia Plate, Left 6 Hole |
00840124508460 | Posterior Lateral Tibia Plate, Left 5 Hole |
00840124508453 | Posterior Fibula Plate Anatomical, Right 11 Hole |
00840124508446 | Posterior Fibula Plate Anatomical, Right 10 Hole |
00840124508439 | Posterior Fibula Plate Anatomical, Right 9 Hole |
00840124508422 | Posterior Fibula Plate Anatomical, Right 8 Hole |