S-Core Implant System
FDA 510(k) K220901 · Subchondral Solutions, Inc.
510(k) numberK220901
Submission
- Device name
- S-Core Implant System
- Applicant
- Subchondral Solutions, Inc.
Huntington Beach, CA, US - Received
- March 28, 2022
- Decision date
- July 29, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was S-Core Implant System cleared by the FDA?
S-Core Implant System (K220901) received a 510(k) decision of Substantially Equivalent on July 29, 2022, 123 days after the submission was received.
What is the product code of K220901?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.