HammerTube™ System P40-001-0350-SK

GUDID 00889795057716

HammerTube™ System Implant Kit, Ø3.50 x 16mm, 0°, Sterile

PARAGON 28, INC.

Interphalangeal joint arthrodesis implant

• Primary Device ID: 00889795057716
• NIH Device Record Key: 43553a43-b549-462e-8fdb-f01bbcbd2e0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HammerTube™ System
• Version Model Number: P40-001-0350-SK
• Catalog Number: P40-001-0350-SK
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00889795057716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171715

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

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: 2023-02-20
• Device Publish Date: 2023-02-10

On-Brand Devices [HammerTube™ System]

• 00889795057723: HammerTube™ System Implant Kit, Ø3.50 x 16mm, 10°, Sterile
• 00889795057716: HammerTube™ System Implant Kit, Ø3.50 x 16mm, 0°, Sterile
• 00889795057709: HammerTube™ System Implant Kit, Ø2.75 x 14mm, 10°, Sterile
• 00889795057693: HammerTube™ System Implant Kit, Ø2.75 x 14mm, 0°, Sterile
• 00889795033994: HammerTube Implant, 3.50mm, 10° Cannulated STERILE
• 00889795033987: HammerTube Implant, 2.75mm, 10° Cannulated STERILE
• 00889795033970: HammerTube Implant, 3.50mm, 0° Cannulated STERILE
• 00889795033963: HammerTube Implant, 2.75mm, 0° Cannulated STERILE
• 00889795128485: HammerTube™ System Implant Kit, Ø3.50 x 16mm, 10°, Sterile
• 00889795128478: HammerTube System Peek Implant, Ø3.50mm x 16mm, 10°, Sterile
• 00889795128461: HammerTube™ System Implant Kit, Ø2.75 x 14mm, 10°, Sterile
• 00889795128454: HammerTube System Peek Implant, Ø2.75mm x 14mm, 10°, Sterile
• 00889795128447: HammerTube™ System Implant Kit, Ø3.50 x 16mm, 0°, Sterile
• 00889795128430: HammerTube System Peek Implant, Ø3.50mm x 16mm, 0°, Sterile
• 00889795128423: HammerTube™ System Implant Kit, Ø2.75 x 14mm, 0°, Sterile
• 00889795128416: HammerTube System Peek Implant, Ø2.75mm x 14mm, 0°, Sterile