Submission Details
| 510(k) Number | K203253 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 04, 2020 |
| Decision Date | December 03, 2020 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Special
NuVasive ACP System
Dec 2020
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K203253 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 December 3, 2020, 29 days after receiving the submission on November 4, 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
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