Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
Intervertebral Fusion Device With Bone Graft, Lumbar
Adcura, Inc.
The following data is part of a premarket notification filed by Adcura, Inc. with the FDA for Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices.
Pre-market Notification Details
| Device ID | K223065 |
| 510k Number | K223065 |
| Device Name: | Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Adcura, Inc. 11010 Prairie Lakes Dr Ste 375 Eden Prairie, MN 55344 |
| Contact | Andrew Rogers |
| Correspondent | Nathan Wright Empirical Technologies 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-30 |
| Decision Date | 2022-10-26 |
Trademark Results [Adcura]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADCURA 90640037 not registered Live/Pending |
SpineEX, Inc. 2021-04-12 |
 ADCURA 86737790 4932139 Live/Registered |
Chicago Tag & Label, Inc. 2015-08-26 |
 ADCURA 85253006 not registered Dead/Abandoned |
Chicago Tag & Label, Inc. 2011-02-28 |
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