Submission Details
| 510(k) Number | K201078 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 22, 2020 |
| Decision Date | May 20, 2020 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Special
NuVasive? ACP System
May 2020
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K201078 is an FDA 510(k) clearance for the NuVasive? ACP System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on May 20, 2020, 28 days after receiving the submission on April 22, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.
Device Classification
| Product Code | KWQ — Appliance, Fixation, Spinal Intervertebral Body |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3060 |
Manufacturer
Similar Devices — KWQ Appliance, Fixation, Spinal Intervertebral Body
All 661
K260015 · SpineCraft
· Mar 2026
K251940 · L & K Biomed Co., Ltd.
· Mar 2026
K254182 · Osteonic Co., Ltd.
· Feb 2026
K253201 · 4Web, Inc.
· Feb 2026
K252611 · Carlsmed, Inc.
· Dec 2025
K251965 · Alphatec Spine, Inc.
· Aug 2025
More from Nu Vasive, Incorporated
View all
K231735
· ODP · Jul 2023
K230894
· OVD · Jun 2023
K230989
· OLO · May 2023
K223181
· NKB · Jan 2023
K221751
· OVD · Oct 2022