Submission Details
| 510(k) Number | K202227 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 07, 2020 |
| Decision Date | September 14, 2020 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Artus? cervical plate system
Sep 2020
Decision
38d
Days
Class 2
Risk
About This 510(k) Submission
K202227 is an FDA 510(k) clearance for the Artus? cervical plate system, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Ulrich GmbH & Co. KG (Ulm, DE). The FDA issued a Cleared decision on September 14, 2020, 38 days after receiving the submission on August 7, 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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