PolyLock Midfoot MF-NL-3514

GUDID 00840124503434

Compression Screw 3.5mm x 14mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00840124503434
• NIH Device Record Key: 78c6fb58-eab6-4d5d-9d61-42135ab659ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyLock Midfoot
• Version Model Number: MF-NL-3514
• Catalog Number: MF-NL-3514
• 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: false
• 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	00840124503434 [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

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

[00840124503434]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-19
• Device Publish Date: 2021-02-11

On-Brand Devices [PolyLock Midfoot]

• 00840124502628: Lapidus Plate Neutral Left
• 00840124502611: Maverick Lapidus Plate 2mm Right
• 00840124502604: Maverick Lapidus Plate 2mm Left
• 00840124502598: Maverick Lapidus Plate Neutral Right
• 00840124502581: Maverick Lapidus Plate Neutral Left
• 00840124502574: Straight Plate Compression 8 Hole
• 00840124502567: Straight Plate Compression 6 Hole
• 00840124502550: Straight Plate Compression 5 Hole
• 00840124502543: Straight Plate Static 4 Hole
• 00840124502536: Straight Plate Compression 2 Hole
• 00840124502529: Straight Plate Static 2 Hole
• 00840124502512: Straight Plate Compression 2 Hole
• 00840124502659: Lapidus Plate 1mm Right
• 00840124502642: Lapidus Plate 1mm Left
• 00840124502635: Lapidus Plate Neutral Right
• 00840124504899: Lag Plate 4 Hole
• 00840124503137: Tapper Threaded Locking Screw 2.7mm x 19mm
• 00840124503120: Tapper Threaded Locking Screw 2.7mm x 18mm
• 00840124503113: Tapper Threaded Locking Screw 2.7mm x 17mm
• 00840124503106: Tapper Threaded Locking Screw 2.7mm x 16mm
• 00840124503090: Tapper Threaded Locking Screw 2.7mm x 15mm
• 00840124503083: Tapper Threaded Locking Screw 2.7mm x 14mm
• 00840124503076: Tapper Threaded Locking Screw 2.7mm x 13mm
• 00840124503069: Tapper Threaded Locking Screw 2.7mm x 12mm
• 00840124503052: Tapper Threaded Locking Screw 2.7mm x 11mm
• 00840124503045: Tapper Threaded Locking Screw 2.7mm x 10mm
• 00840124503038: Tapper Threaded Locking Screw 2.7mm x 9mm
• 00840124503021: Tapper Threaded Locking Screw 2.7mm x 8mm
• 00840124502956: LisFranc Plate Small Left
• 00840124502949: LisFranc Plate Small Right
• 00840124502932: LisFranc Plate Medium Left
• 00840124502925: LisFranc Plate Medium Right
• 00840124502918: LisFranc Plate Large Left
• 00840124502901: LisFranc Plate Large Right
• 00840124502895: L-Plate Compression 6 Hole Right
• 00840124502888: L-Plate Compression 6 Hole Right
• 00840124502871: L-Plate Compression 5 Hole Left
• 00840124502864: L-Plate Compression 5 Hole Right
• 00840124502857: L-Plate Compression 4 Hole left
• 00840124502840: L-Plate Compression 4 Hole Right
• 00840124502833: MTP Dorsal Plate Revision Right 10 °
• 00840124502826: MTP Dorsal Plate Revision Left 10 °
• 00840124502819: MTP Dorsal Plate Revision Neutral Right
• 00840124502802: MTP Dorsal Plate Revision Neutral Left
• 00840124502796: MTP Dorsal Plate Large Right 10 °
• 00840124502789: MTP Dorsal Plate Large Neutral Right
• 00840124502772: MTP Dorsal Plate Large Left 10 °
• 00840124502765: MTP Dorsal Plate Neutral Large Left
• 00840124502758: MTP Dorsal Plate Small Right 10 °
• 00840124502741: MTP Dorsal Plate Small Right Neutral