Fine Osteotomy implants - Proximal tibia 015-410-107

GUDID 00688346000511

Proximal tibia, plate, screws (cortical locking/compression)

Laboratoires Bodycad Inc

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

• Primary Device ID: 00688346000511
• NIH Device Record Key: 2fca709b-2da2-4883-a272-a96e2fe9bab6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fine Osteotomy implants - Proximal tibia
• Version Model Number: 015-410-107
• Catalog Number: 015-410-107
• 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	00688346000511 [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

[00688346000511]

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 - Proximal tibia]

• 00688346002331: Tibial plate, cortical locking screws, cancellous compressionscrews
• 00688346002324: Tibial plate, Cortical compression screws, Cancellous compression screws
• 00688346002386: Tibial plate, cortical locking screws , cortical compression screws
• 00688346002379: Tibial plate, cortical locking screws
• 00688346002362: Tibial plate, cortical compression screws
• 00688346002355: Tibial plate, cortical locking screws, cortical compression screws, cancellous compression sc
• 00688346002348: Tibial plate, cancellous compression screws
• 00688346000511: Proximal tibia, plate, screws (cortical locking/compression)
• 00688346000504: Proximal tibia, plate, cortical locking screws
• 00688346000498: Proximal tibia, plate, cortical compression screws
• 00688346000481: Proximal tibia, plate, screws (cortical locking/compression, cancellous compression)
• 00688346000474: Proximal tibia, plate, cancellous compression screws
• 00688346000467: Proximal tibia, plate, screws (cortical locking, cancellous compression)
• 00688346000122: Proximal tibia, plate, screws (cortical/cancellous compression)