FDA 510(k)

VersaTap, VersaLat, DueLock, VersaTi, MiniTi

K-Number: K212381 · 2021-12-06

Decision Date2021-12-06

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VersaTap, VersaLat, DueLock, VersaTi, MiniTi is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Design (Pty), Ltd.. It received FDA 510(k) clearance on 2021-12-06 under 510(k) 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. The listed applicant is Ortho-Design (Pty), Ltd.. The 510(k) number is K212381.

When did VersaTap, VersaLat, DueLock, VersaTi, MiniTi receive FDA 510(k) clearance?

VersaTap, VersaLat, DueLock, VersaTi, MiniTi received FDA 510(k) clearance on 2021-12-06, under 510(k) number K212381.

Who is the listed applicant for VersaTap, VersaLat, DueLock, VersaTi, MiniTi?

The FDA 510(k) record lists Ortho-Design (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Ortho-Design (Pty), Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)

Related Devices (Code: MBI)

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy K261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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.