Monkey Bars™ Pin to Bar External Fixation System P47-410-0400

GUDID 00889795114792

11mm x 400mm Carbon Bar

PARAGON 28, INC.

External orthopaedic fixation system, single-use

• Primary Device ID: 00889795114792
• NIH Device Record Key: 345fed8b-e1aa-421c-a8d3-a6d345de88ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monkey Bars™ Pin to Bar External Fixation System
• Version Model Number: P47-410-0400
• Catalog Number: P47-410-0400
• 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: 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	00889795114792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211112

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

[00889795114792]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-22
• Device Publish Date: 2022-09-14

On-Brand Devices [Monkey Bars™ Pin to Bar External Fixation System]

• 00889795116420: Monkey Bars™ Sterilization Case Base
• 00889795116413: Monkey Bars™ Sterilization Case Tray 2
• 00889795116406: Monkey Bars™ Sterilization Case Tray 1
• 00889795116390: Monkey Bars™ Sterilization Case Lid
• 00889795114921: 10mm wrench
• 00889795114914: T-wrench/pin driver
• 00889795114907: Trocar for Tissue Protector
• 00889795114891: Tissue Protector Sleeve
• 00889795114884: Tissue Protector w/Handle
• 00889795114860: 4.0mm x 200mm Calibrated Step Drill
• 00889795114853: 3.2mm x 165mm Calibrated Step Drill
• 00889795114846: 2.4mm x 140mm Calibrated Step Drill
• 00889795114839: 30 Degree angled post
• 00889795114822: Straight Post
• 00889795114815: 11mm x 500mm Carbon Bar
• 00889795114808: 11mm x 450mm Carbon Bar
• 00889795114792: 11mm x 400mm Carbon Bar
• 00889795114785: 11mm x 350mm Carbon Bar
• 00889795114778: 11mm x 300mm Carbon Bar
• 00889795114761: 11mm x 250mm Carbon Bar
• 00889795114754: 11mm x 200mm Carbon Bar
• 00889795114747: 11mm x 150mm Carbon Bar
• 00889795114730: 8 hole pin clamp
• 00889795114723: 5 hole pin clamp
• 00889795114716: 11mm bar to 11mm bar/5mm pin
• 00889795114709: 5mm Pin Cap (10 Pack)
• 00889795114693: 5mm x 325mm Transfixation Pin, Centrally Threaded
• 00889795114686: 5mm x 65mm Half Pin, 200mm length (Blunt Tipped)
• 00889795114679: 5mm x 65mm Half Pin, 200mm length (Self Tapping)
• 00889795114662: 5mm x 55mm Half Pin, 200mm length (Blunt Tipped)
• 00889795114655: 5mm x 55mm Half Pin, 200mm length (Self Tapping)
• 00889795114648: 5mm x 45mm Half Pin, 150mm length (Blunt Tipped)
• 00889795114631: 5mm x 45mm Half Pin, 150mm length (Self Tapping)
• 00889795114624: 5mm x 35mm Half Pin, 150mm length (Blunt Tipped)
• 00889795114617: 5mm x 35mm Half Pin, 150mm length (Self Tapping)
• 00889795114600: 4mm x 30mm Half Pin (Blunt Tipped)
• 00889795114594: 4mm x 30mm Half Pin (Self Tapping)
• 00889795114587: 4mm x 20mm Half Pin (Blunt Tipped)
• 00889795114570: 4mm x 20mm Half Pin (Self Tapping)
• 00889795114563: 3mm x 20mm Half Pin (Blunt Tipped)
• 00889795114556: 3mm x 20mm Half Pin (Self Tapping)
• 00889795114877: Sterilization Case
• 00889795145963: Ratcheting T-Handle, AO and 10mm Socket
• 00889795145956: T-Handle, AO and 10mm Socket
• 00889795145949: 5mm Trocar
• 00889795145932: Fixation Pin Drill Sleeve
• 00889795145925: Fixation Pin Drill Sleeve w/ Handle
• 00889795145918: Step Drill, 4.0 x 200mm
• 00889795145901: Step Drill, 3.2 x 165mm
• 00889795145895: Step Drill, 2.4 x 140mm