CUVIS-spine
Orthopedic Stereotaxic Instrument
Curexo, Inc.
The following data is part of a premarket notification filed by Curexo, Inc. with the FDA for Cuvis-spine.
Pre-market Notification Details
| Device ID | K201569 |
| 510k Number | K201569 |
| Device Name: | CUVIS-spine |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Curexo, Inc. 577, Gangnam-Daero, Seocho-Gu Seoul, KR 06530 |
| Contact | Jungeun Park |
| Correspondent | Do Hyun Kim BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, KR 06210 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-11 |
| Decision Date | 2021-05-19 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800043830006 | K201569 | 000 |
Trademark Results [CUVIS-spine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CUVIS-SPINE 79358787 not registered Live/Pending |
CUREXO Inc. 2022-11-07 |
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