Control 360

GUDID 00853114006006

Triplanar Deformity Correction

TREACE MEDICAL CONCEPTS, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00853114006006
• NIH Device Record Key: 1c94223a-2999-4532-8cb7-c538762976c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control 360
• Version Model Number: SK12
• Company DUNS: 054808082
• Company Name: TREACE MEDICAL CONCEPTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	00853114006006 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-05-18
• Device Publish Date: 2016-05-27

Devices Manufactured by TREACE MEDICAL CONCEPTS, INC.

• 00810111225366 - Saw Blade: 2026-02-03 Dorsal Akin Saw Blade - ZMS
• 00810111225236 - Lapiplasty SpeedPlate - TMT: 2026-02-02 Locking Screws
• 00810111225397 - Guide: 2026-02-02 Targeting Guide
• 00810111225403 - Guide: 2026-02-02 Targeting Guide
• 00810111225472 - Drill Guide: 2026-02-02 Drill Guide and Template
• 00810111225342 - Saw Blade: 2026-01-15 DORSAL AKINATOR™ BLADE - ZMS
• 00810111226677 - Positioner / Compressor: 2026-01-13 Lightning Block - 3-N-1 adapter
• 00810111226684 - Positioner / Compressor: 2026-01-13 Lightning Block - Distal Left