DualX
Intervertebral Fusion Device With Bone Graft, Lumbar
Amplify Surgical, Inc.
The following data is part of a premarket notification filed by Amplify Surgical, Inc. with the FDA for Dualx.
Pre-market Notification Details
| Device ID | K211740 |
| 510k Number | K211740 |
| Device Name: | DualX |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Amplify Surgical, Inc. 9272 Jeronimo Rd Suite 107B Irvine, CA 92618 |
| Contact | Andy Choi |
| Correspondent | Meredith May Empirical Testing Corp. 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 | 2021-06-07 |
| Decision Date | 2021-09-29 |
Trademark Results [DualX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUALX 87198136 5788186 Live/Registered |
IMDS, LLC 2016-10-10 |
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