MectaLock Extension
FDA 510(k) K203493 · Medacta International S.A.
510(k) numberK203493
Submission
- Device name
- MectaLock Extension
- Applicant
- Medacta International S.A.
Castel San Pietro (Ch), CH - Received
- November 27, 2020
- Decision date
- February 22, 2021
- 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 MectaLock Extension cleared by the FDA?
MectaLock Extension (K203493) received a 510(k) decision of Substantially Equivalent on February 22, 2021, 87 days after the submission was received.
What is the product code of K203493?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.