VersaTap, VersaLat, DueLock, VersaTi, MiniTi
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212381 FDA 510(k)
- FDA Product Code
- MBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an orthopedic implant system comprising multiple components: VersaTap, VersaLat, DueLock, VersaTi, VersaTi, and MiniTi. It is designed for use in orthopedic surgical procedures.
The device was cleared through the FDA 510(k) process under K212381 with a traditional clearance pathway and found substantially equivalent to a predicate device. It is manufactured by ORTHO-DESIGN (PTY) LTD in Pretoria, South Africa, and is classified under product code MBI with advisory committee review in orthopedics (OR).
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212381 | Class II | Active |
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Manufacturer
- Manufacturer
- Ortho-Design (pty) Ltd
- FDA Applicant
- Ortho-Design (Pty), Ltd.
Sources (1)
- FDA 510(k) K212381 24 fields · synced Sep 21, 2026