Submission Details
| 510(k) Number | K231208 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 27, 2023 |
| Decision Date | August 14, 2023 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
Stryker Resorbable Fixation System
Aug 2023
Decision
109d
Days
Class 2
Risk
About This 510(k) Submission
K231208 is an FDA 510(k) clearance for the Stryker Resorbable Fixation System, a Fastener, Plate, Cranioplasty (Class II — Special Controls, product code HBW), submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on August 14, 2023, 109 days after receiving the submission on April 27, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5360.
Device Classification
| Product Code | HBW — Fastener, Plate, Cranioplasty |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5360 |
Manufacturer
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