OTIS EVO90FA500

GUDID 03760154008143

Complete instrumentation set composed of reusable surgical instruments intended to be used for high tibial osteotomy.

S.B.M

General surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03760154008143
• NIH Device Record Key: 41bcba12-159c-4e9b-9763-110d75d48dea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTIS
• Version Model Number: OTIS complete instrumentation set for HTO
• Catalog Number: EVO90FA500
• Company DUNS: 772462123
• Company Name: S.B.M
• 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: true
• 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	03760154008143 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

[03760154008143]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-20
• Device Publish Date: 2024-06-12

On-Brand Devices [OTIS]

• 03760154001090: Impactor tip to be used with OTIS implants for HTO.
• 03760154001083: Impactor body to be used with OTIS implants for HTO.
• 03760154000932: Instrument for use with OTIS implants for HTO.
• 03760154000925: Instrument for use with OTIS implants for HTO.
• 03760154000918: Instrument for use with OTIS implants for HTO.
• 03760154000901: Instrument for use with OTIS implants for HTO.
• 03760154000895: Instrument for use with OTIS implants for HTO.
• 03760154000888: Instrument for use with OTIS implants for HTO.
• 03760154000871: Instrument for use with OTIS implants for HTO.
• 03760154000864: Instrument for use with OTIS implants for HTO.
• 03760154000857: Instrument for use with OTIS implants for HTO.
• 03760154000840: Instrument for use with OTIS implants for HTO.
• 03760154008129: Screwdriver for OTIS® screw extraction
• 03760154006262: Slotted hammer for OTIS metallic trial implants, to be used with OTIS implants for HTO.
• 03760154006255: Handle for OTIS metallic trial implants, to be used with OTIS implants for HTO.
• 03760304680809: OTIS cleaning and sterilization basket.
• 03760154008143: Complete instrumentation set composed of reusable surgical instruments intended to be used for h