Baby Gorilla® / Gorilla® Plating System P50-453-2770

GUDID 00889795145550

Gorilla®, R3CON™ Screw, Ø2.7 x 70mm, Non-Locking, Solid, TiA

Paragon 28, Inc.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00889795145550
• NIH Device Record Key: 3b3f295c-8fc6-40fe-8f04-2fbd033d3eef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baby Gorilla® / Gorilla® Plating System
• Version Model Number: P50-453-2770
• Catalog Number: P50-453-2770
• 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	00889795145550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241262

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: 2025-04-25
• Device Publish Date: 2025-04-17

On-Brand Devices [Baby Gorilla® / Gorilla® Plating System]

• 00889795150011: Gorilla®, R3CON™ Screw, Ø2.7 x 74mm, Non-Locking, Solid, TiA
• 00889795150004: Gorilla®, R3CON™ Screw, Ø2.7 x 72mm, Non-Locking, Solid, TiA
• 00889795145864: Ankle Fracture 360, 2.7/3.5 mm Screw Caddy, Base
• 00889795145574: Gorilla®, R3CON™ Screw, Ø2.7 x 80mm, Non-Locking, Solid, TiA
• 00889795145567: Gorilla®, R3CON™ Screw, Ø2.7 x 75mm, Non-Locking, Solid, TiA
• 00889795145550: Gorilla®, R3CON™ Screw, Ø2.7 x 70mm, Non-Locking, Solid, TiA
• 00889795145543: Gorilla®, R3CON™ Screw, Ø2.7 x 68mm, Non-Locking, Solid, TiA
• 00889795145536: Gorilla®, R3CON™ Screw, Ø2.7 x 66mm, Non-Locking, Solid, TiA
• 00889795145529: Gorilla®, R3CON™ Screw, Ø2.7 x 65mm, Non-Locking, Solid, TiA
• 00889795145512: Gorilla®, R3CON™ Screw, Ø2.7 x 64mm, Non-Locking, Solid, TiA
• 00889795145505: Gorilla®, R3CON™ Screw, Ø2.7 x 62mm, Non-Locking, Solid, TiA
• 00889795099686: Gorilla®, R3CON™ Screw, Ø2.7 x 60mm, Non-Locking, Solid, TiA
• 00889795099679: Gorilla®, R3CON™ Screw, Ø2.7 x 58mm, Non-Locking, Solid, TiA
• 00889795099662: Gorilla®, R3CON™ Screw, Ø2.7 x 56mm, Non-Locking, Solid, TiA