Stryker Leibinger Skeletal Anchoring System
FDA 510(k) K041651 · Stryker Leibinger
510(k) numberK041651
Submission
- Device name
- Stryker Leibinger Skeletal Anchoring System
- Applicant
- Stryker Leibinger
Kalamazoo, MI, US - Received
- June 17, 2004
- Decision date
- September 30, 2004
- 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 Leibinger Skeletal Anchoring System cleared by the FDA?
Stryker Leibinger Skeletal Anchoring System (K041651) received a 510(k) decision of Substantially Equivalent on September 30, 2004, 105 days after the submission was received.
What is the product code of K041651?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.