Positioner / Compressor

GUDID 00810111226691

LIGHTNING BLOCK - PROXIMAL LEFT

Treace Medical Concepts, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00810111226691
• NIH Device Record Key: 0285f636-31f9-4f59-84e9-3c2abd381b04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Positioner / Compressor
• Version Model Number: 02-00515
• Company DUNS: 054808082
• Company Name: Treace Medical Concepts, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00810111226691 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[00810111226691]

Moist Heat or Steam Sterilization

[00810111226691]

Moist Heat or Steam Sterilization

[00810111226691]

Moist Heat or Steam Sterilization

[00810111226691]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-02
• Device Publish Date: 2026-02-20

On-Brand Devices [Positioner / Compressor]

• 00810111226707: Lightning Block - Threaded Knob
• 00810111226684: Lightning Block - Distal Left
• 00810111226677: Lightning Block - 3-N-1 adapter
• 00810111226691: LIGHTNING BLOCK - PROXIMAL LEFT