Small Bone Phantom Intramedullary Nail System P30-L1-5560

GUDID 00889795038913

Lapidus Nail, Left, 60mm

PARAGON 28, INC.

Arthrodesis nail, non-sterile Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length

• Primary Device ID: 00889795038913
• NIH Device Record Key: 057cf197-3a32-4eec-b456-1d7a13b5c46d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Small Bone Phantom Intramedullary Nail System
• Version Model Number: P30-L1-5560
• Catalog Number: P30-L1-5560
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00889795038913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182307

FDA Product Code

• KTW: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Sterilization

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

[00889795038913]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-25
• Device Publish Date: 2019-10-17

On-Brand Devices [Small Bone Phantom Intramedullary Nail System]

• 00889795055170: Lapidus Cut Guide Caddy Lid
• 00889795055163: MET-CUNEIFORM GUIDE, RIGHT 6°
• 00889795055156: MET-CUNEIFORM GUIDE, RIGHT 2°
• 00889795055149: MET-CUNEIFORM GUIDE, LEFT 6°
• 00889795055132: MET-CUNEIFORM GUIDE, LEFT 4°
• 00889795055125: MET-CUNEIFORM GUIDE, LEFT 2°
• 00889795055118: Lapidus Cut Guide Caddy II
• 00889795055101: MET-CUNEIFORM GUIDE, RIGHT 4°
• 00889795055095: MIS Lapidus, Burr Guide
• 00889795055088: MIS Lapidus, Burr Guide, Paddle
• 00889795055071: MIS Lapidus, Flute Cleaner
• 00889795055064: MIS Lapidus Burr Guide Caddy
• 00889795052933: Lapidus Nail, 3-Hole, Right, 60mm
• 00889795052926: Lapidus Nail, 3-Hole, Right, 58mm
• 00889795052919: Lapidus Nail, 3-Hole, Right, 56mm
• 00889795052902: Lapidus Nail, 3-Hole, Right, 54mm
• 00889795052896: Lapidus Nail, 3-Hole, Right, 52mm
• 00889795052889: Lapidus Nail, 3-Hole, Right, 50mm
• 00889795052872: Lapidus Nail, 3-Hole, Right, 48mm
• 00889795052865: Lapidus Nail, 3-Hole, Right, 46mm
• 00889795052858: Lapidus Nail, 3-Hole, Right, 44mm
• 00889795052841: Lapidus Nail, 3-Hole, Right, 42mm
• 00889795052834: Lapidus Nail, 3-Hole, Right, 40mm
• 00889795052827: Lapidus Nail, 3-Hole, Right, 38mm
• 00889795052810: Lapidus Nail, 3-Hole, Left, 60mm
• 00889795052803: Lapidus Nail, 3-Hole, Left, 58mm
• 00889795052797: Lapidus Nail, 3-Hole, Left, 56mm
• 00889795052780: Lapidus Nail, 3-Hole, Left, 54mm
• 00889795052773: Lapidus Nail, 3-Hole, Left, 52mm
• 00889795052766: Lapidus Nail, 3-Hole, Left, 50mm
• 00889795052759: Lapidus Nail, 3-Hole, Left, 48mm
• 00889795052742: Lapidus Nail, 3-Hole, Left, 46mm
• 00889795052735: Lapidus Nail, 3-Hole, Left, 44mm
• 00889795052728: Lapidus Nail, 3-Hole, Left, 42mm
• 00889795052711: Lapidus Nail, 3-Hole, Left, 40mm
• 00889795052544: Lapidus Nail, 2.75mm Wire Depth Gauge
• 00889795052537: Lapidus Nail, Tissue Protector
• 00889795052520: Lapidus Nail, Torque Indicating Driver, T10
• 00889795052513: PHANTOM Nail, Tube Cap, Sphere Wire
• 00889795052506: PHANTOM Nail, Tube Cap, Standard
• 00889795052490: PHANTOM Nail, Sphere Wire Tube
• 00889795052483: PHANTOM Nail, 2.3mm K-Wire Tube
• 00889795052476: PHANTOM Nail, 2.0mm K-Wire Tube
• 00889795052469: PHANTOM Nail, 1.6mm K-Wire Tube
• 00889795052452: PHANTOM Screw Caddy Base
• 00889795052445: PHANTOM Screw Caddy Lid
• 00889795052438: PHANTOM Nail Caddy Base
• 00889795052421: PHANTOM Nail Caddy Lid
• 00889795052414: PHANTOM Instrument Tray
• 00889795052407: PHANTOM Case Lid