Primary Device ID | 00840124505414 |
NIH Device Record Key | a7b98670-353b-42ed-8a00-714304a9d666 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PolyLock Ankle Plates |
Version Model Number | AK-PT-1505 |
Catalog Number | AK-PT-1505 |
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 | 00840124505414 [Primary] |
HRS | Plate, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
[00840124505414]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-01-25 |
Device Publish Date | 2022-01-17 |
00840124505889 | Lateral Fibula Plate Anatomical Right 11 Hole |
00840124505872 | Lateral Fibula Plate Anatomical Right 10 Hole |
00840124505865 | Lateral Fibula Plate Anatomical Right 9 Hole |
00840124505858 | Lateral Fibula Plate Anatomical Right 8 Hole |
00840124505483 | Utility Straight Plate 6 Hole |
00840124505476 | Utility Straight Plate 5 Hole |
00840124505469 | Utility Straight Plate 4 Hole |
00840124505452 | Utility Straight Plate 3 Hole |
00840124505445 | Posterior Lateral Tibia Plate Right 8 Hole |
00840124505438 | Posterior Lateral Tibia Plate Right 7 Hole |
00840124505421 | Posterior Lateral Tibia Plate Right 6 Hole |
00840124505414 | Posterior Lateral Tibia Plate Right 5 Hole |
00840124505407 | Posterior Lateral Tibia Plate Left 8 Hole |
00840124505391 | Posterior Lateral Tibia Plate Left 7 Hole |
00840124505384 | Posterior Lateral Tibia Plate Left 6 Hole |
00840124505377 | Posterior Lateral Tibia Plate Left 5 Hole |
00840124505360 | Posterior Fibula Plate Anatomical Right 11 Hole |
00840124505353 | Posterior Fibula Plate Anatomical Right 10 Hole |
00840124505346 | Posterior Fibula Plate Anatomical Right 9 Hole |
00840124505339 | Posterior Fibula Plate Anatomical Right 8 Hole |
00840124505322 | Posterior Fibula Plate Anatomical Left 11 Hole |
00840124505315 | Posterior Fibula Plate Anatomical Left 10 Hole |
00840124505308 | Posterior Fibula Plate Anatomical Left 9 Hole |
00840124505292 | Posterior Fibula Plate Anatomical Left 8 Hole |
00840124505285 | Medial Malleolus Plate 9 Hole |
00840124505278 | Medial Malleolus Plate 8 Hole |
00840124505261 | Medial Malleolus Plate 7 Hole |
00840124505254 | Lateral Fibula Plate Universal 13 Hole |
00840124505247 | Lateral Fibula Plate Universal 11 Hole |
00840124505230 | Lateral Fibula Plate Universal 9 Hole |
00840124505223 | Lateral Fibula Hook Plate Small |
00840124505216 | Lateral Fibula Plate Anatomical Left 11 Hole |
00840124505209 | Lateral Fibula Plate Anatomical, Left 10 Hole |
00840124505193 | Lateral Fibula Plate Anatomical, Left 9 Hole |
00840124505186 | Lateral Fibula Plate Anatomical, Left 8 Hole |
00840124505681 | Utility Straight Plate Revision 11 Hole |
00840124505674 | Utility Straight Plate Revision 10 Hole |
00840124505667 | Utility Straight Plate Revision 9 Hole |
00840124505650 | Utility Straight Plate Revision 8 Hole |
00840124505643 | AK-UP-9007 |
00840124505636 | Utility Straight Plate Revision 6 Hole |
00840124505629 | Utility Straight Plate Revision 5 Hole |
00840124505612 | Utility Straight Plate Revision 4 Hole |
00840124505605 | Utility Straight Plate Revision 3 Hole |
00840124505582 | Utility Straight Plate 16 Hole |
00840124505575 | AK-UP-0015 |
00840124505568 | Utility Straight Plate 14 Hole |
00840124505551 | Utility Straight Plate 13 Hole |
00840124505544 | Utility Straight Plate 12 Hole |
00840124505537 | Utility Straight Plate 11 Hole |