OptimalMTP™ 6102.1911

GUDID 00810136433401

RADIOLUCENT POSITIONING WEDGE, LEFT, 10 DEGREES

Forma Medical, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00810136433401
• NIH Device Record Key: dfae9331-660d-47d6-84d7-1bbc10e917e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptimalMTP™
• Version Model Number: 6102.1911
• Catalog Number: 6102.1911
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810136433401 [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

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

[00810136433401]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-02
• Device Publish Date: 2025-05-23

On-Brand Devices [OptimalMTP™]

• 00810136432954: 1.6mm Olive K-wire, 4 in. Long
• 00810136432947: 1.4mm Olive K-wire, 4 in. Long
• 00810136433425: RADIOLUCENT POSITIONING WEDGE, RIGHT, 10 DEGREES
• 00810136433418: RADIOLUCENT POSITIONING WEDGE, RIGHT, 5 DEGREES
• 00810136433401: RADIOLUCENT POSITIONING WEDGE, LEFT, 10 DEGREES
• 00810136433395: RADIOLUCENT POSITIONING WEDGE, LEFT, 5 DEGREES
• 00810136433388: Radiolucent Foot Plate