Opti-Toe-Small Angle OT-SA

GUDID M621OTSA0

The Opti-Toe-Small Angle Implant is comprised of two mated components (proximal and middle phalangeal) which join together to form a single intramedullary fixation unit. Indications: The GraMedica opti-Toe Device is indicate for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect weight-bearing or heal bearing until healing has occurred.

Gramedica

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: M621OTSA0
• NIH Device Record Key: 2f0932b5-7a19-4bd6-b529-1b5e99ab70af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opti-Toe-Small Angle
• Version Model Number: OT-SA
• Catalog Number: OT-SA
• Company DUNS: 828660345
• Company Name: Gramedica
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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
HIBCC	M621OTSA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142478

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-26
• Device Publish Date: 2017-02-14

Devices Manufactured by Gramedica

• M621CARRYINGCASE0 - osteo-WEDGE Opening Wedge Bone Locking System: 2021-10-26 osteo-WEDGE Opening Wedge Bone Locking System -Kit (containing non-sterile single use implants (2.5mm locking bone screws, 3.0mm
• M621CP1505FG0 - HyProCure Sizer 05: 2021-10-26 HyProCure Sizer 05. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a
• M621CP1506FG0 - HyProCure Sizer 06: 2021-10-26 HyProCure Sizer 06. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is
• M621CP1507FG0 - HyProCure Sizer 07: 2021-10-26 HyProCure Sizer 07. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a
• M621CP1508FG0 - HyProCure Sizer 08: 2021-10-26 HyProCure Sizer 08. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a
• M621CP1509FG0 - HyProCure Sizer 09: 2021-10-26 HyProCure Sizer 09. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a
• M621CP1510FG0 - HyProCure Sizer 10: 2021-10-26 HyProCure Sizer 10. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is
• M621GM150010 - osteo-WEDGE Depth Gauge Sleeve: 2021-10-26 osteo-WEDGE Depth Gauge Sleeve, a reusable instrument, for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System.