510(k) K212381
K212381 is an FDA 510(k) premarket notification submitted by Ortho-Design (Pty), Ltd. for the device "VersaTap, VersaLat, DueLock, VersaTi, MiniTi". The FDA issued a decision of Substantially Equivalent on December 6, 2021. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Ortho-Design (Pty), Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2021
- Date Received
- August 2, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type