Dorsal TMT I Fusion Plate 1mm, left Sterile

GUDID M209209480

BIOPRO, INC.

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: M209209480
• NIH Device Record Key: 2f5d0b74-00cf-48e1-89b4-972cabdfac0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dorsal TMT I Fusion Plate 1mm, left Sterile
• Version Model Number: 20948
• Company DUNS: 618749857
• Company Name: BIOPRO, 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: 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
HIBCC	M209209480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162674

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2017-08-13

Devices Manufactured by BIOPRO, INC.

• M209230790 - MTP FUSION PLATE 5 DEGREE, LEFT: 2024-04-03
• M209230800 - MTP FUSION PLATE 5 DEGREE, RIGHT: 2024-04-03
• M209230810 - MTP FUSION PLATE 0 DEGREE, LEFT: 2024-04-03
• M209230820 - MTP FUSION PLATE 0 DEGREE, RIGHT: 2024-04-03
• M209230830 - MTP FUSION PLATE, NARROW 10 DEGREE, LEFT: 2024-04-03
• M20923084 - MTP FUSION PLATE, NARROW 10 DEGREE, RIGHT: 2024-04-03
• M20923085 - MTP FUSION PLATE, NARROW 5 DEGREE, LEFT: 2024-04-03
• M209230860 - MTP FUSION PLATE, NARROW 5 DEGREE, RIGHT: 2024-04-03