PolyLock Ankle Plates AK-UP-0012

GUDID 00840124505544

Utility Straight Plate 12 Hole

FUSION ORTHOPEDICS, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00840124505544
• NIH Device Record Key: a57c7d79-8391-4956-a101-e9bca27e4f75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyLock Ankle Plates
• Version Model Number: AK-UP-0012
• Catalog Number: AK-UP-0012
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840124505544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202959

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

[00840124505544]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-27
• Device Publish Date: 2022-01-19

On-Brand Devices [PolyLock Ankle Plates]

• 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