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

[00810136433449]

Moist Heat or Steam Sterilization

[00810136433449]

Moist Heat or Steam Sterilization

[00810136433449]

Moist Heat or Steam Sterilization

[00810136433449]

Moist Heat or Steam Sterilization

[00810136433449]

Moist Heat or Steam Sterilization

[00810136433449]

Moist Heat or Steam Sterilization

[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

On-Brand Devices [OptimalTMT™]

• 00810136433449: MIS Lapidus Clamp Medial Pad
• 00810136433463: Titanium Long MIS Lapidus S-Plate, Right, 4 hole
• 00810136433456: Titanium Long MIS Lapidus S-Plate, Left, 4 hole
• 00810136433487: LONG MIS Lapidus Targeting Instrument, Right
• 00810136433470: LONG MIS Lapidus Targeting Instrument, Left