Fine Osteotomy implants - Proximal tibia 015-410-103

GUDID 00688346002348

Tibial plate, cancellous compression screws

Laboratoires Bodycad Inc

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

• Primary Device ID: 00688346002348
• NIH Device Record Key: 7e741f30-c51a-43c6-9a89-bdb6de20b61a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fine Osteotomy implants - Proximal tibia
• Version Model Number: 015-410-103
• Catalog Number: 015-410-103
• 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	00688346002348 [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

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

[00688346002348]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-13
• Device Publish Date: 2021-12-03

On-Brand Devices [Fine Osteotomy implants - Proximal tibia]

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• 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)