PointCloud Knee Instruments

GUDID TKRL000115KK0

Unik Orthopedics Inc.

Total knee prosthesis implantation guide-instrument kit

• Primary Device ID: TKRL000115KK0
• NIH Device Record Key: 6d2be5bf-17bc-44ed-8be2-841314fe40ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PointCloud Knee Instruments
• Version Model Number: UKI0201-L
• Company DUNS: 118205691
• Company Name: Unik Orthopedics 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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
HIBCC	TKRL000115KK0 [Primary]

FDA Product Code

• OOG: Knee Arthroplasty Implantation System

Sterilization

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

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

[TKRL000115KK0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-08
• Device Publish Date: 2024-09-30

On-Brand Devices [PointCloud Knee Instruments]

• TKRR000111L00: UKI0201-R
• TKRR0001111K0: UKI0201-R
• TKRR000110B50: UKI0201-R
• TKRL000115KK0: UKI0201-L
• TKRL000113D70: UKI0201-L
• TKRL000112II0: UKI0201-L
• TKRL0001124I0: UKI0201-L