The Brachiator Mini External Fixation System P46-101-2000

GUDID 00889795152046

Hinged Rail, Short Segment, female

Paragon 28, Inc.

External orthopaedic fixation system noninvasive component, single-use

• Primary Device ID: 00889795152046
• NIH Device Record Key: 707a4877-59ca-435c-89f0-62f64cf9a0dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Brachiator Mini External Fixation System
• Version Model Number: P46-101-2000
• Catalog Number: P46-101-2000
• 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: 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	00889795152046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252106

FDA Product Code

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

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: 2025-12-24
• Device Publish Date: 2025-12-16

On-Brand Devices [The Brachiator Mini External Fixation System]

• 00889795152077: Mini Rail, Case 1 of 1, Case Lid
• 00889795152060: Mini Rail, Case 1 of 1, Case Base
• 00889795152053: Hinged Rail, Locking Assembly
• 00889795152046: Hinged Rail, Short Segment, female
• 00889795152039: Hinged Rail, Short Segment, male
• 00889795152022: Cut Guide, Side Slot
• 00889795152015: Pin Template, 40mm of Travel
• 00889795152008: K-wire Sleeve
• 00889795151995: AO Male to 7mm and D-slot Female Adaptor
• 00889795151988: Stubby Combination Wrench, 7mm
• 00889795151971: Hex L Key, 3mm
• 00889795151964: Driver, Patient
• 00889795151957: 7mm and D-slot Female T-Handle Driver with Male 3mm Hex
• 00889795151940: Pin Covers
• 00889795151933: Half Pin, Ø1.6 x 60mm OAL x 15mm THD
• 00889795151926: Half Pin, Ø2.0 x 60mm OAL x 20mm THD
• 00889795151919: Half Pin, Ø2.0 x 100mm OAL x 25mm THD
• 00889795151902: Half Pin, Ø3.0 x 60mm OAL x 20mm THD
• 00889795151896: Half Pin, Ø3.0 x 100mm OAL x 33mm THD
• 00889795151889: Carriage Pin Rotating
• 00889795151872: Carriage Basic
• 00889795151865: Rotating Adapter
• 00889795151858: Long 75mm of travel
• 00889795151841: Standard 40mm of travel
• 00889795151834: Hinged Rail, 20mm of travel, male
• 00889795151827: Hinged Rail, 20mm of travel, female