Submission Details
| 510(k) Number | K233360 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2023 |
| Decision Date | February 29, 2024 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Curiteva Thoracolumbar Plate System
Feb 2024
Decision
153d
Days
Class 2
Risk
About This 510(k) Submission
K233360 is an FDA 510(k) clearance for the Curiteva Thoracolumbar Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on February 29, 2024, 153 days after receiving the submission on September 29, 2023. 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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