JAWS® Nitinol Staple System P71-012-1212-S

GUDID 00889795130655

JAWS Staple, 12mm, 12 x 12 Straight

PARAGON 28, INC.

Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00889795130655
• NIH Device Record Key: c9bc98ac-cc5d-4e97-b052-97baee26492d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JAWS® Nitinol Staple System
• Version Model Number: P71-012-1212-S
• Catalog Number: P71-012-1212-S
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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	00889795130655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170923

FDA Product Code

• JDR: Staple, fixation, bone

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: 2023-05-26
• Device Publish Date: 2023-05-18

On-Brand Devices [JAWS® Nitinol Staple System]

• 00889795130655: JAWS Staple, 12mm, 12 x 12 Straight
• 00889795124234: JAWs Great White Nitinol Staple System, 25 x 20 x 20mm, Straight Staple Kit
• 00889795124227: JAWs Great White Nitinol Staple System, 20 x 20 x 20mm, Straight Staple Kit
• 00889795124210: JAWs Great White Nitinol Staple System, 18 x 18 x 18mm, Straight Staple Kit
• 00889795124203: JAWs Great White Nitinol Staple System, 15 x 15 x 15mm, Straight Staple Kit
• 00889795124197: JAWs Great White Nitinol Staple System, 12 x 12 x 12mm, Straight Staple Kit