VersaTap, VersaLat, DueLock, VersaTi, MiniTi
K-Number: K212381 · 2021-12-06
ApplicantOrtho-Design (Pty), Ltd.
Decision Date2021-12-06
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
VersaTap, VersaLat, DueLock, VersaTi, MiniTi is a medical device manufactured by Ortho-Design (Pty), Ltd.. It received FDA 510(k) clearance on 2021-12-06 under approval number K212381. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VersaTap, VersaLat, DueLock, VersaTi, MiniTi?
VersaTap, VersaLat, DueLock, VersaTi, MiniTi is a medical device that received FDA 510(k) clearance on 2021-12-06. It is manufactured by Ortho-Design (Pty), Ltd.. The 510(k) number is K212381.
When was VersaTap, VersaLat, DueLock, VersaTi, MiniTi approved by the FDA?
VersaTap, VersaLat, DueLock, VersaTi, MiniTi received FDA 510(k) clearance on 2021-12-06, under approval number K212381.
What company makes VersaTap, VersaLat, DueLock, VersaTi, MiniTi?
VersaTap, VersaLat, DueLock, VersaTi, MiniTi is manufactured by Ortho-Design (Pty), Ltd..
What is the FDA product code for VersaTap, VersaLat, DueLock, VersaTi, MiniTi?
The FDA product code for VersaTap, VersaLat, DueLock, VersaTi, MiniTi is MBI.
Other Devices by Ortho-Design (Pty), Ltd.
Related Devices (Code: MBI)
K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.
K162198GFS UltimateParcus Medical, LLC
K162386KATOR Suture AnchorKator, LLC
K161033AFX Femoral Implant With InserterCayenne Medical, Inc.
K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC
K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.