Precision MIS Bunion System P27-135-0028

GUDID 00889795131737

Precision MIS Screw, Cannulated, Ø3.5 x 28mm

PARAGON 28, INC.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00889795131737
• NIH Device Record Key: f142a4fa-bece-44d7-876d-439b28a7e5f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision MIS Bunion System
• Version Model Number: P27-135-0028
• Catalog Number: P27-135-0028
• 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	00889795131737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190586

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-01
• Device Publish Date: 2024-01-24

On-Brand Devices [Precision MIS Bunion System]

• 00889795133083: Screw Caddy Lid
• 00889795133076: Screw Caddy Base
• 00889795133069: Instrument Tray 2
• 00889795133052: Instrument Tray 1
• 00889795133045: Case Base
• 00889795133038: Case Lid
• 00889795133021: Curved Elevator
• 00889795133014: Straight Elevator
• 00889795133007: K-wire Tube, Ø4.0 Screw
• 00889795132994: K-wire Tube, Ø3.5 Screw
• 00889795132987: K-wire Tube, Ø3.0 Screw
• 00889795132970: Drill Guide Tube, Medial Screw, 4.0 Drill
• 00889795132963: Drill Guide Tube, Medial Screw, 3.5 Drill
• 00889795132956: Drill Guide Tube, Medial Screw, 3.0 Drill
• 00889795132949: Drill Guide Tube, Lateral Screw, 4.0 Drill
• 00889795132932: Drill Guide Tube, Lateral Screw, 3.5 Drill
• 00889795132925: Drill Guide Tube, Lateral Screw, 3.0 Drill
• 00889795132918: Screw Tube, Lateral Screw, Common
• 00889795132901: Parallel K-Wire Guide, Handled, Ø3.5 and Ø4.0 Screws
• 00889795132895: Parallel K-Wire Guide, Handled, Ø3.0 Screw
• 00889795132888: Drill Guide/Soft Tissue Protector (double sided), Handled, Ø4.0 Screw
• 00889795132871: Drill Guide/Soft Tissue Protector (double sided), Handled, Ø3.5 Screw
• 00889795132864: Drill Guide/Soft Tissue Protector (double sided), Handled, Ø3.0 Screw
• 00889795132857: Cleaning wire
• 00889795132840: Reduction Wire
• 00889795132833: Freer Elevator
• 00889795132826: Countersink, Ø4.0 Screw
• 00889795132819: Countersink, Ø3.5 Screw
• 00889795132802: Countersink, Ø3.0 Screw
• 00889795132796: Angel Wing
• 00889795132789: Outrigger, Left
• 00889795132772: Outrigger, Right
• 00889795132765: Depth Gauge, Common
• 00889795132758: Sterilization Container, K-wire, Outrigger Fixation
• 00889795132741: Sterilization Container for Ø1.7 x 230mm K-wire
• 00889795132734: Sterilization Container for Ø1.6 x 230mm K-wire
• 00889795132727: Sterilization Container for Ø1.2 x 230mm K-wire
• 00889795132710: Ø1.7 x 230mm Smooth K-wire for Ø4.0 Screw
• 00889795132703: Ø1.6 x 230mm Smooth K-wire for Ø3.5 Screw
• 00889795132697: Ø1.2 x 230mm Smooth K-wire for Ø3.0 Screw
• 00889795132680: K-wire, 2.0mm x 100mm
• 00889795132604: Ø3.5 Driver, Cannulated Long
• 00889795132598: Ø3.0 Driver, Cannulated Long
• 00889795132581: Ø3.0mm Cannulated Drill for Ø4.0 Screw, Short
• 00889795132574: Ø2.7mm Cannulated Drill for Ø3.5 Screw, Short
• 00889795132567: Ø2.4mm Cannulated Drill for Ø3.0 Screw, Short
• 00889795132550: Ø2.4mm Cannulated Drill for Ø3.0 Screw, Long
• 00889795132222: Precision MIS Screw, Cannulated, Ø4.0 x 70mm
• 00889795132215: Precision MIS Screw, Cannulated, Ø4.0 x 68mm
• 00889795132208: Precision MIS Screw, Cannulated, Ø4.0 x 66mm