Stem Trial 8.5MM

GUDID M209173460

BIOPRO, INC.

Orthopaedic implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: M209173460
• NIH Device Record Key: 905b6276-f0d6-4448-9004-bba62a515623
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stem Trial 8.5MM
• Version Model Number: 17346
• 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: false
• 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	M209173460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061089

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

[M209173460]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-06
• Device Publish Date: 2019-05-03

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• 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