Stryker Leibinger Resorbable Fixation System
FDA 510(k) K993061 · Stryker Instruments
510(k) numberK993061
Submission
- Device name
- Stryker Leibinger Resorbable Fixation System
- Applicant
- Stryker Instruments
Kalamazoo, MI, US - Received
- September 13, 1999
- Decision date
- November 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Stryker Leibinger Resorbable Fixation System cleared by the FDA?
Stryker Leibinger Resorbable Fixation System (K993061) received a 510(k) decision of Substantially Equivalent on November 19, 1999, 67 days after the submission was received.
What is the product code of K993061?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.