LSI Arthroereisis Peg SG-LD-0003-S

GUDID 00819034029549

LSI Implant Large

FUSION ORTHOPEDICS, LLC

Subtalar implant, non-bioabsorbable, sterile

• Primary Device ID: 00819034029549
• NIH Device Record Key: d6ef2c44-f893-4a4e-b2f5-fdbabe8d627b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LSI Arthroereisis Peg
• Version Model Number: SG-LD-0003-S
• Catalog Number: SG-LD-0003-S
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: true
• 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
GS1	00819034029549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922292

FDA Product Code

• MJW: Prosthesis, Subtalar, Plug, Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-02
• Device Publish Date: 2020-11-24

On-Brand Devices [LSI Arthroereisis Peg]

• 00852164007995: Trephine Long
• 00819034029426: Drill Guide Large
• 00819034029419: Drill Guide Medium
• 00819034029402: Drill Guide Small
• 00819034029396: Sizer Large Plus
• 00819034029389: Sizer Large
• 00819034029372: Sizer Medium Plus
• 00819034029365: Sizer Medium
• 00819034029358: Sizer Small Plus
• 00819034029341: Sizer Small
• 00819034029334: Starter Awl Right
• 00819034029327: TN-LD-4001 Starter Awl
• 00819034029310: Angled Awl 45 Degree
• 00819034029303: Trephine Short
• 00819034029556: LSI Implant Large Plus
• 00819034029549: LSI Implant Large
• 00819034029532: LSI ImplantMedium Plus
• 00819034029525: LSI Implant Medium
• 00819034029518: LSI Implant Small Plus
• 00819034029501: LSI Implant Small
• 00819034029495: Trial Large Plus
• 00819034029488: Trial Large
• 00819034029471: Trial Medium Plus
• 00819034029464: Trial Medium
• 00819034029457: Trial Small Plus
• 00819034029440: Trial Small
• 00819034029433: LSI Drill 4.9 mm