eZ-Fix 320-BA

GUDID 00841132141212

Extender, Adapter blunt

ORTHOPEDIATRICS CORP.

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00841132141212
• NIH Device Record Key: 31dbc9bb-ee62-4b56-a2cf-2304eb7f5eb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eZ-Fix
• Version Model Number: 320-BA
• Catalog Number: 320-BA
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• 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: true
• 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@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132141212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052196

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

Moist Heat or Steam Sterilization

[00841132141212]

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 [eZ-Fix]

• 00841132141113: FootPlate, Full 160mm Silver w/Tabs
• 00841132184585: Nut, Thread coupling 80mm
• 00841132184578: Nut, Thread coupling 70mm
• 00841132184561: Nut, Thread coupling 50mm
• 00841132184554: Nut, Thread coupling 30mm
• 00841132184547: Nut, Thread coupling 20mm
• 00841132180716: Tensioner, Long Nose
• 00841132179758: Moving Carriage, Rotating Base
• 00841132179741: Moving Carriage, Mid Clamp
• 00841132179734: Moving Carriage, Anti-Rotation Base
• 00841132179727: Moving Carriage Cap
• 00841132179710: M3.5x0.6-6 SHCS Bolt, Lock Screw
• 00841132179703: M3.5x0.6-17 SHCS Bolt, Double Stack Screw
• 00841132179697: M3.5x0.6-12 SHCS Bolt, Single Stack Screw
• 00841132179680: Hex Key Tool
• 00841132179673: End Clamp, Fixed, Mid Clamp
• 00841132179666: End Clamp Cap
• 00841132179659: Dual Track Rail
• 00841132179642: Carriage Subassembly for M700-090 Rail
• 00841132179635: Rail, Micro 90mm w/3 Stationary Carriages
• 00841132179628: Rail, Mini 100mm Gold
• 00841132179611: Rail, Mini 80mm Gold
• 00841132179604: Rail, Mini 100mm Black
• 00841132179598: Rail, Mini 80mm Black
• 00841132179581: Rail, Micro 90mm Gold
• 00841132179574: Wire Trocar 1.8x400mm
• 00841132179550: Wire Trocar Olive 1.8x400mm
• 00841132179536: Wire Drill Tip Olive 1.8x400mm
• 00841132179529: Wire Drill tip 1.8x400mm
• 00841132179505: Wire Bayonet Pear 1.8x400mm
• 00841132179444: Wire Bayonet 1.8x400mm
• 00841132179437: Wire Trocar 1.5 x 400mm
• 00841132179406: Wire Drill Tip Olive 1.5x400mm
• 00841132179390: Wire Drill Tip 1.5x400mm
• 00841132179383: Wire ConeShape Drill Tip 1.5x400mm
• 00841132179369: Wire Bayonet Olive 1.5x400mm
• 00841132179307: Wire Bayonet 1.5x400mm
• 00841132143056: Rail, Three carriage
• 00841132143049: Rail, Mini Articular 2 sides
• 00841132143032: Rail, Mini Articular 1 side
• 00841132143025: Wrench, T 3.0mm
• 00841132143018: Wrench, Ratchet
• 00841132143001: Wrench, Flex Swivel Socket Head, 10mm
• 00841132142998: Wrench, Combo 14mm
• 00841132142981: Wrench, Combo 13mm
• 00841132142974: Wrench, Combo 10mm
• 00841132142967: Wrench, Cannulated 10mm L CP
• 00841132142950: T wrench 3.0mm
• 00841132142943: Rail , Half Moon Half-Pin Inserter
• 00841132142936: Rail Dual-End Half-Pin Inserter