Orthopediatrics Instrumentation 01-1007-1232

GUDID 00841132173138

1.6mm Mini Tack, 40mm, Threaded

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00841132173138
• NIH Device Record Key: f29a5ff3-7b22-4809-a68d-2d5e1a8a4dd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthopediatrics Instrumentation
• Version Model Number: 01-1007-1232
• Catalog Number: 01-1007-1232
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• 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: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatric.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132173138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151881

FDA Product Code

• HRS: Plate, fixation, bone
• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

[00841132173138]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-02-28

On-Brand Devices [Orthopediatrics Instrumentation]

• 00841132177211: Wire Caddy
• 00841132174463: 1.6mm wire collet
• 00841132174456: 2.0mm wire collet
• 00841132174449: Articulating distractor
• 00841132174418: Tendon Passer, 2.4mm x 400mm
• 00841132174401: Tendon Passer, 2.4mm x 300mm
• 00841132174371: 1.6mm Mini Tack, 40mm, Smooth
• 00841132174364: 1.6mm Mini Tack, 35mm, Smooth
• 00841132174357: 1.6mm Mini Tack, 40mm, Threaded
• 00841132174340: 1.6mm Mini Tack, 35mm, Threaded
• 00841132174333: 1.6mm Mini Tack, 30mm, Smooth
• 00841132173138: 1.6mm Mini Tack, 40mm, Threaded
• 00841132177501: 6.5mm Fully Threaded Cannulated Screw Caddy
• 00841132177495: 7.3mm Fully Threaded Cannulated Screw Caddy
• 00841132177488: 6.5/7.3mm Cannulated Screw Instrument Tray Long
• 00841132177464: 6.5mm Partially Threaded Cannulated Screw Caddy
• 00841132177457: 7.3mm Partially Threaded Cannulated Screw Caddy
• 00841132177440: 6.5/7.3mm Cannulated Screw Instrument Tray Short
• 00841132177433: Long 6.5/7.3 SCFE Base Tray
• 00841132177259: LARGE FRENCH BENDERS
• 00841132177242: 6.5mm Fully Threaded Cannulated Screw Caddy
• 00841132177235: 7.3mm Partially Threaded Cannulated Screw Caddy
• 00841132177228: 7.3mm Fully Threaded Cannulated Screw Caddy
• 00841132177204: RETAINING SLEEVE DRIVER, LONG
• 00841132177198: RETAINING SLEEVE DRIVER, SHORT
• 00841132177174: RETAINING SLEEVE DRIVER, LONG
• 00841132176863: 3.2mm Cleaning Stylet, Long
• 00841132176627: 6.5mm/7.3mm Cannulated Screw retaining Sleeve, Short
• 00841132176603: 2.7MM/3.5MM WRIST FUSION PLATE BENDING TEMPLATE, 99MM
• 00841132176573: 4.5MM LOCKING SCREW GUIDE - OUTER TUBE
• 00841132176566: 4.5MM LOCKING SCREW GUIDE - INNER TUBE
• 00841132176559: 3.5MM LOCKING SCREW GUIDE - OUTER TUBE
• 00841132176542: 3.5MM LOCKING SCREW GUIDE - INNER TUBE
• 00841132175644: 3.2mm Cleaning Stylet, Short
• 00841132175637: 3.2mm SCFE Wire Guide Inserter, Short
• 00841132175620: Cannulated Countersink 6.5/7.3mm screw, Long
• 00841132175613: Cannulated Countersink 6.5/7.3mm screw, Short
• 00841132175606: Direct Measuring Device, 3.2 x 300mm Wire
• 00841132175590: Direct Measuring Device - 3.2 x 375mm Wire
• 00841132175583: Zimmer Inline Ratcheting Handle, Cannulated
• 00841132174388: 1.25mm Guide Wire Caddy
• 00841132174241: 5.0mm Hex Driver, Retaining, Cannulated, Long
• 00841132174234: 2.7mm Cannulated Drill, Long
• 00841132174227: 5.6/3.2 Double Drill Guide
• 00841132174210: 4.0/2.0 Double Drill Guide
• 00841132174203: 3.2/1.6 Double Drill Guide
• 00841132174197: 5.0mm Hex Driver, Retaining, Cannulated, Short
• 00841132174180: 2.7mm Cannulated Drill, Short
• 00841132174173: 9.25mm Trephine
• 00841132174166: 4.5mm Locking Compression Femur Case Inner Tray