HammerTube System P40-900-3500

GUDID 00889795039378

Implant Inserter, 3.5mm

PARAGON 28, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00889795039378
• NIH Device Record Key: feb6493b-fc93-4eb7-b850-368d85a50e6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HammerTube System
• Version Model Number: P40-900-3500
• Catalog Number: P40-900-3500
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	00889795039378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171715

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

[00889795039378]

Moist Heat or Steam Sterilization

[00889795039378]

Moist Heat or Steam Sterilization

[00889795039378]

Moist Heat or Steam Sterilization

[00889795039378]

Moist Heat or Steam Sterilization

[00889795039378]

Moist Heat or Steam Sterilization

[00889795039378]

Moist Heat or Steam Sterilization

[00889795039378]

Moist Heat or Steam Sterilization

[00889795039378]

Moist Heat or Steam Sterilization

[00889795039378]

Moist Heat or Steam Sterilization

[00889795039378]

Moist Heat or Steam Sterilization

[00889795039378]

Moist Heat or Steam Sterilization

[00889795039378]

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 [HammerTube System]

• 00889795057679: HammerTube Implant, 3.50mm, 10° Cannulated
• 00889795057662: HammerTube Implant, 2.75mm, 10° Cannulated
• 00889795057655: HammerTube Implant, 3.50mm, 0° Cannulated
• 00889795057648: HammerTube Implant, 2.75mm, 0° Cannulated
• 00889795041616: K-Wire, Double Ended Trocar Tip, 1.6mm x 150mm
• 00889795041609: K-Wire, Double Ended Trocar Tip, 1.4mm x 150mm
• 00889795041517: Drill Insert Trocar Tip, 1.6mm x 70mm (Patent Pending)
• 00889795041500: Drill Insert Trocar Tip, 1.4mm x 70mm (Patent Pending)
• 00889795041494: Drill Insert Trocar Tip, 1.1mm x 70mm (Patent Pending)
• 00889795039392: Hammertoe, Implant Puller
• 00889795039385: HammerTube Extractor Tool
• 00889795039378: Implant Inserter, 3.5mm
• 00889795039361: Implant Inserter, 2.8mm
• 00889795039354: Implant Inserter, 2.75mm
• 00889795039347: Implant Inserter, 2.3mm
• 00889795039323: K-Wire, Double Ended Trocar Tip, 1.6mm x 30mm, Blunt
• 00889795039316: K-Wire, Double Ended Trocar Tip, 1.4mm x 30mm, Blunt
• 00889795039309: K-Wire, Double Ended Trocar Tip, 1.1mm x 30mm, Blunt
• 00889795039446: Drill, 2.75mm, Cannulated (Patent Pending)
• 00889795039439: Drill, 2.65mm, Cannulated (Patent Pending)
• 00889795039422: Drill, 2.15mm, Cannulated (Patent Pending)
• 00889795097415: HammerToe, Caddy, Lid
• 00889795097408: HammerToe, Caddy, Insert
• 00889795097392: HammerToe, Caddy, Base
• 00889795039453: Drill, 3.5mm, Cannulated (Patent Pending)
• 00889795039330: Bone Planer, 8mm (Patent Pending)
• 00889795057686: HammerToe Implant X-ray Overlay (HammerGraft & Hammertube)
• 00889795039415: Trephine Ø3.50mm
• 00889795039408: Trephine Ø2.75mm