510(k) K191995
K191995 is an FDA 510(k) premarket notification submitted by Subchondral Solutions, Inc. for the device "S4 Screw System". The FDA issued a decision of Substantially Equivalent on Apr 18, 2020. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Subchondral Solutions, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 18, 2020
- Date Received
- Jul 26, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)