OptimalTMT™ 6102.8009

GUDID 00810136433449

MIS Lapidus Clamp Medial Pad

Forma Medical, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00810136433449
• NIH Device Record Key: 8928414e-56dc-4506-9bbb-6b3ce7ae3615
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptimalTMT™
• Version Model Number: 6102.8009
• Catalog Number: 6102.8009
• Company DUNS: 126585966
• Company Name: Forma Medical, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810136433449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230945

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00810136433449]

Moist Heat or Steam Sterilization

[00810136433449]

Moist Heat or Steam Sterilization

[00810136433449]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-04
• Device Publish Date: 2025-06-26

Devices Manufactured by Forma Medical, Inc.

• 00810136433159 - Burr: 2025-07-04 MIS Doty Burr, 4x13mm, Reverse Wedge
• 00810136433449 - OptimalTMT™: 2025-07-04MIS Lapidus Clamp Medial Pad
• 00810136433449 - OptimalTMT™: 2025-07-04 MIS Lapidus Clamp Medial Pad
• 00810136433388 - OptimalMTP™: 2025-06-02 Radiolucent Foot Plate
• 00810136433395 - OptimalMTP™: 2025-06-02 RADIOLUCENT POSITIONING WEDGE, LEFT, 5 DEGREES
• 00810136433401 - OptimalMTP™: 2025-06-02 RADIOLUCENT POSITIONING WEDGE, LEFT, 10 DEGREES
• 00810136433418 - OptimalMTP™: 2025-06-02 RADIOLUCENT POSITIONING WEDGE, RIGHT, 5 DEGREES
• 00810136433425 - OptimalMTP™: 2025-06-02 RADIOLUCENT POSITIONING WEDGE, RIGHT, 10 DEGREES
• 00810136432237 - OptimalMTP®: 2025-02-03 Titanium 3.5mm Non-Locking Screw, 50mm Long