PolyLock

GUDID 00840124511132

Universal Cut Guide Kit

FUSION ORTHOPEDICS, LLC

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00840124511132
• NIH Device Record Key: eed75203-02c7-4a95-9a36-a3adb2f2c92b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyLock
• Version Model Number: CD-MF-1000-S
• 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: true
• 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	00840124511132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211843

FDA Product Code

• KDD: Kit, Surgical Instrument, Disposable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-09
• Device Publish Date: 2024-04-01

On-Brand Devices [PolyLock]

• 00840124501003: Locking Screw SB 2.0mm x 30mm
• 00840124500990: Locking Screw SB 2.0mm x 28mm
• 00840124500983: Locking Screw SB 2.0mm x 26mm
• 00840124500976: Locking Screw SB 2.0mm x 24mm
• 00840124500242: Non-Locking Screw SB 2.0mm x 22mm
• 00840124500235: Non-Locking Screw SB 2.0mm x 20mm
• 00840124500228: Non-Locking Screw SB 2.0mm x 18mm
• 00840124500211: Non-Locking Screw SB 2.0mm x 16mm
• 00840124500204: Non-Locking Screw SB 2.0mm x 14mm
• 00840124500198: Non-Locking Screw SB 2.0mm x 12mm
• 00840124500181: Non-Locking Screw SB 2.0mm x 10mm
• 00840124500174: Non-Locking Screw SB 2.0mm x 8mm
• 00840124500167: Locking Screw SB 2.0mm x 22mm
• 00840124500150: Locking Screw SB 2.0mm x 20mm
• 00840124500143: Locking Screw SB 2.0mm x 18mm
• 00840124500136: Locking Screw SB 2.0mm x 16mm
• 00840124500129: Locking Screw SB 2.0mm x 14mm
• 00840124500112: Locking Screw SB 2.0mm x 12mm
• 00840124500105: Locking Screw SB 2.0mm x 10mm
• 00840124500099: Locking Screw SB 2.0mm x 8mm
• 00840124500082: T-Plate SB 8 Hole
• 00840124500075: T-Plate SB 7 Hole
• 00840124500068: T-Plate SB 6 Hole
• 00840124500051: T-Plate SB 5 Hole
• 00840124500044: Straight Plate SB 8 Hole
• 00840124500037: Straight Plate SB 6 Hole
• 00840124500020: Straight Plate SB 5 Hole
• 00840124500013: Straight Plate SB 4 Hole Static
• 00840124500006: Straight Plate SB 3 Hole
• 00819034029990: Straight Plate SB 2 Hole Static
• 00819034029983: Straight Plate SB 2 Hole
• 00819034029976: Hook Plate SB Right
• 00819034029969: Hook Plate SB Left
• 00819034029952: Jones Fracture Plate SB Right
• 00819034029945: Jones Fracture Plate SB Left
• 00819034029938: Evans Plate SB 12mm
• 00819034029921: Evans Plate SB 10mm
• 00819034029914: Evans Plate SB 8mm
• 00819034029907: Evans Plate SB 6mm
• 00819034029891: Evans Plate SB Neutral
• 00819034029884: Cotton Plate SB 8mm
• 00819034029877: Cotton Plate SB 6mm
• 00819034029860: Cotton Plate SB 4mm
• 00819034029853: Cotton Plate SB Neutral
• 00840124501102: Opening Wedge Plate SB 5mm
• 00819034027040: Opening Wedge Plate SB 4mm
• 00819034027033: Opening Wedge Plate SB 3mm
• 00840124501041: Non-Locking Screw SB 2.0mm x 30mm
• 00840124501034: Non-Locking Screw SB 2.0mm x 28mm
• 00840124501027: Non-Locking Screw SB 2.0mm x 26mm