Fine osteotomy System 025-006

GUDID 00688346000191

Implant-Screw Caddy

Laboratoires Bodycad Inc

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

• Primary Device ID: 00688346000191
• NIH Device Record Key: f637bd59-ec24-4f65-b62e-a3790f8dbfe8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fine osteotomy System
• Version Model Number: 025-006
• Catalog Number: 025-006
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00688346000191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211646

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

[00688346000191]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-22
• Device Publish Date: 2021-12-13

Devices Manufactured by Laboratoires Bodycad Inc

• 00688346000047 - Fine Osteotomy system - Proximal tibia: 2024-02-19 Proximal tibia, plate, screws (compression cortical/cancellous), guides
• 00688346000078 - Fine Osteotomy system - Distal femur: 2024-02-19 Distal femur, plate, screws (compression cortical/cancellous), guides
• 00688346000108 - Fine Osteotomy implants - Distal femur: 2024-02-19 Distal femur, plate, screws (cortical/cancellous compression)
• 00688346000122 - Fine Osteotomy implants - Proximal tibia: 2024-02-19 Proximal tibia, plate, screws (cortical/cancellous compression)
• 00688346000283 - Fine Osteotomy system - Distal femur: 2024-02-19 Distal femur, plate, screws (cortical locking, cancellous compression), guides
• 00688346000290 - Fine Osteotomy system - Distal femur: 2024-02-19 Distal femur, plate, cancellous screws compression, guides
• 00688346000320 - Fine Osteotomy system - Distal femur: 2024-02-19 Distal femur, plate, cortical locking screws, guides
• 00688346000337 - Fine Osteotomy system - Distal femur: 2024-02-19 Distal femur, plate, screws (cortical locking, cortical compression), guides