PRECICE Intramedullary Limb Lengthening System LSB3-065

GUDID 00887517936233

Locking Screw, 3.5x65mm

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00887517936233
• NIH Device Record Key: 64f84f50-1051-445e-8e46-76f73c50ceef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECICE Intramedullary Limb Lengthening System
• Version Model Number: LSB3-065
• Catalog Number: LSB3-065
• Company DUNS: 837845234
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517936233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170346

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[00887517936233]

Moist Heat or Steam Sterilization

[00887517936233]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-10
• Device Publish Date: 2018-08-09

On-Brand Devices [PRECICE Intramedullary Limb Lengthening System]

• 00812258021627: 5.0 mm Locking Screw 75 mm Length
• 00812258021610: 5.0 mm Locking Screw 70 mm Length
• 00812258021603: 5.0 mm Locking Screw 65 mm Length
• 00812258021597: 5.0 mm Locking Screw 60 mm Length
• 00812258021580: 5.0 mm Locking Screw 55 mm Length
• 00812258021573: 5.0 mm Locking Screw 50 mm Length
• 00812258021566: 5.0 mm Locking Screw 45 mm Length
• 00812258021559: 5.0 mm Locking Screw 40 mm Length
• 00812258021542: 5.0 mm Locking Screw 35 mm Length
• 00812258021535: 5.0 mm Locking Screw 30 mm Length
• 00812258021528: 5.0 mm Locking Screw 25 mm Length
• 00812258021511: 5.0 mm Locking Screw 20 mm Length
• 00812258021504: 4.0 mm Locking Screw 60 mm Length
• 00812258021498: 4.0 mm Locking Screw 55 mm Length
• 00812258021481: 4.0 mm Locking Screw 50 mm Length
• 00812258021474: 4.0 mm Locking Screw 45 mm Length
• 00812258021467: 4.0 mm Locking Screw 40 mm Length
• 00812258021450: 4.0 mm Locking Screw 35 mm Length
• 00812258021443: 4.0 mm Locking Screw 30 mm Length
• 00812258021436: 4.0 mm Locking Screw 25 mm Length
• 00812258021429: 4.0 mm Locking Screw 20 mm Length
• 00812258021412: 3.5 mm Locking Screw 60 mm Length
• 00812258021405: 3.5 mm Locking Screw 55 mm Length
• 00812258021399: 3.5 mm Locking Screw 50 mm Length
• 00812258021382: 3.5 mm Locking Screw 45 mm Length
• 00812258021375: 3.5 mm Locking Screw 40 mm Length
• 00812258021368: 3.5 mm Locking Screw 35 mm Length
• 00812258021351: 3.5 mm Locking Screw 30 mm Length
• 00812258021344: 3.5 mm Locking Screw 25 mm Length
• 00812258021337: 3.5 mm Locking Screw, 20 mm Length
• 00856719002992: 5.0 mm Locking Screw 75 mm Length
• 00856719002985: 5.0 mm Locking Screw 70 mm Length
• 00856719002978: 5.0 mm Locking Screw 65 mm Length
• 00856719002961: 5.0 mm Locking Screw 60 mm Length
• 00856719002954: 5.0 mm Locking Screw 55 mm Length
• 00856719002947: 5.0 mm Locking Screw 50 mm Length
• 00856719002930: 5.0 mm Locking Screw 45 mm Length
• 00856719002923: 5.0 mm Locking Screw 40 mm Length
• 00856719002916: 5.0 mm Locking Screw 35 mm Length
• 00856719002909: 5.0 mm Locking Screw 30 mm Length
• 00856719002893: 5.0 mm Locking Screw 25 mm Length
• 00856719002886: 5.0 mm Locking Screw 20 mm Length
• 00856719002848: 4.0 mm Locking Screw 60 mm Length
• 00856719002831: 4.0 mm Locking Screw 55 mm Length
• 00856719002824: 4.0 mm Locking Screw 50 mm Length
• 00856719002817: 4.0 mm Locking Screw 45 mm Length
• 00856719002800: 4.0 mm Locking Screw 40 mm Length
• 00856719002794: 4.0 mm Locking Screw 35 mm Length
• 00856719002787: 4.0 mm Locking Screw 30 mm Length
• 00856719002770: 4.0 mm Locking Screw 25 mm Length