PolyLock Ankle TN-AK-7000

GUDID 00840124506060

Hook Plate Guide Fibula

FUSION ORTHOPEDICS, LLC

Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use

• Primary Device ID: 00840124506060
• NIH Device Record Key: 1540c459-9ffe-43bc-861e-30d4a92256d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyLock Ankle
• Version Model Number: TN-AK-7000
• Catalog Number: TN-AK-7000
• 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	00840124506060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202959

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

[00840124506060]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-31
• Device Publish Date: 2022-01-21

On-Brand Devices [PolyLock Ankle]

• 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