Total Knee Instrumentation

GUDID 00840097534947

GAP BALANCING SPOON, 1MM

Restor3d, Inc.

Joint prosthesis implantation kit, reusable

• Primary Device ID: 00840097534947
• NIH Device Record Key: 0de751c4-e10e-4530-bd27-3e1ea9083ca2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Knee Instrumentation
• Version Model Number: 5201-1001
• Company DUNS: 080819836
• Company Name: Restor3d, Inc.
• 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: 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	00840097534947 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840097534947]

Moist Heat or Steam Sterilization

[00840097534947]

Moist Heat or Steam Sterilization

[00840097534947]

Moist Heat or Steam Sterilization

[00840097534947]

Moist Heat or Steam Sterilization

[00840097534947]

Moist Heat or Steam Sterilization

[00840097534947]

Moist Heat or Steam Sterilization

[00840097534947]

Moist Heat or Steam Sterilization

[00840097534947]

Moist Heat or Steam Sterilization

[00840097534947]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-25
• Device Publish Date: 2025-10-10

On-Brand Devices [Total Knee Instrumentation ]

• 00840097534961: GAP BALANCING SPOON, 3MM
• 00840097534954: GAP BALANCING SPOON, 2MM
• 00840097534947: GAP BALANCING SPOON, 1MM