Stryker Resorbable Fixation System
FDA 510(k) K231208 · Stryker Leibinger GmbH & Co KG
510(k) numberK231208
Submission
- Device name
- Stryker Resorbable Fixation System
- Applicant
- Stryker Leibinger GmbH & Co KG
Freiburg, DE - Received
- April 27, 2023
- Decision date
- August 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Stryker Resorbable Fixation System cleared by the FDA?
Stryker Resorbable Fixation System (K231208) received a 510(k) decision of Substantially Equivalent on August 14, 2023, 109 days after the submission was received.
What is the product code of K231208?
The FDA product code is HBW – Fastener, Plate, Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5360.