MEGAFIX® Pedicle Screw Spinal System
Thoracolumbosacral Pedicle Screw System
SeohanCare Co., Ltd
The following data is part of a premarket notification filed by Seohancare Co., Ltd with the FDA for Megafix® Pedicle Screw Spinal System.
Pre-market Notification Details
| Device ID | K191655 |
| 510k Number | K191655 |
| Device Name: | MEGAFIX® Pedicle Screw Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SeohanCare Co., Ltd 2F Da-dong 22, Gimpo-daero 2918beon-gil, Wolgot-myeon Gimpo-si, KR 10020 |
| Contact | Chae Lynn Song |
| Correspondent | Meredith May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-21 |
| Decision Date | 2020-03-06 |
Trademark Results [MEGAFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEGAFIX 97101513 not registered Live/Pending |
Woosam Medical CO., LTD 2021-10-31 |
 MEGAFIX 88925144 not registered Live/Pending |
S3 Concrete Technologies, Inc. 2020-05-20 |
 MEGAFIX 79037065 3520754 Dead/Cancelled |
IBC Solar AG 2007-01-31 |
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