Fine Osteotomy implants - Distal femur 015-330-101

GUDID 00688346000108

Distal femur, plate, screws (cortical/cancellous compression)

Laboratoires Bodycad Inc

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00688346000108
• NIH Device Record Key: 6cac0dad-edfe-4767-b369-1e30002002e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fine Osteotomy implants - Distal femur
• Version Model Number: 015-330-101
• Catalog Number: 015-330-101
• Company DUNS: 202981171
• Company Name: Laboratoires Bodycad 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00688346000108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193614

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00688346000108]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-19
• Device Publish Date: 2020-05-20

On-Brand Devices [Fine Osteotomy implants - Distal femur]

• 00688346002188: 015-330-104
• 00688346002164: Femoral Plate, Cortical Locking Screws, Cancellous Compression Screws
• 00688346002157: Femoral plate, Cortical Compression Screws, Cancellous Compression Screws
• 00688346000399: Distal femur, plate, screws (cortical locking, cortical compression)
• 00688346000382: Distal femur, plate, cortical locking screws
• 00688346000375: Distal femur, plate, cortical compression screws
• 00688346000368: Distal femur, plate, screws (cortical locking, cortical/ cancellous compression)
• 00688346000351: Distal femur, plate, cancellous compression screws
• 00688346000344: Distal femur, plate, screws (cortical locking, cancellous compression)
• 00688346000108: Distal femur, plate, screws (cortical/cancellous compression)