eZ-Fix 630-01
GUDID 00841132142684
Washer, Thick
ORTHOPEDIATRICS CORP.
External orthopaedic fixation system, single-use, non-sterile| Primary Device ID | 00841132142684 |
| NIH Device Record Key | a75b3320-3edb-4614-951a-904b41e7db4a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | eZ-Fix |
| Version Model Number | 630-01 |
| Catalog Number | 630-01 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841132142684 [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 |
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
Moist Heat or Steam Sterilization
[00841132142684]
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 |
Trademark Results [eZ-Fix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EZ-FIX 77523634 3894330 Live/Registered |
Vilex in Tennessee, Inc. 2008-07-16 |
 EZ-FIX 75012125 2257418 Dead/Cancelled |
BIODYNAMIC TECHNOLOGIES, INC. 1995-10-30 |
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