LSI Arthroereisis Peg TN-LD-5501

GUDID 00819034029358

Sizer Small Plus

FUSION ORTHOPEDICS, LLC

Orthopaedic implant/trial-implant/sizer holder, single-use Orthopaedic implant/trial-implant/sizer holder, single-use Orthopaedic implant/trial-implant/sizer holder, single-use Orthopaedic implant/trial-implant/sizer holder, single-use Orthopaedic implant/trial-implant/sizer holder, single-use Orthopaedic implant/trial-implant/sizer holder, single-use Orthopaedic implant/trial-implant/sizer holder, single-use Orthopaedic implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use

• Primary Device ID: 00819034029358
• NIH Device Record Key: 228c220a-9408-4819-ad77-6b68193ccfa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LSI Arthroereisis Peg
• Version Model Number: TN-LD-5501
• Catalog Number: TN-LD-5501
• 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	00819034029358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922292

FDA Product Code

• MJW: Prosthesis, Subtalar, Plug, Polymer

Sterilization

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

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

[00819034029358]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-30
• Device Publish Date: 2020-11-20

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