FDA.report

510(k) K212381

Device
VersaTap, VersaLat, DueLock, VersaTi, MiniTi
Applicant
Ortho-Design (Pty), Ltd.
510(k) number
K212381
Product code
MBI
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-06
Date received
2021-08-02
Regulation
888.3040
Classification name
Fastener, Fixation, Nondegradable, Soft Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Dian Peach
Address
472 Botterklapper St., Die Wilgers Pretoria ZA 0184 0184

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
06009712642236VersaPEEKORTHO-DESIGN (PTY) LTD2025-08-11
06009712642823Anchor Threaded Titanium-PEEKORTHO-DESIGN (PTY) LTD2023-12-07
06009712642731Anchor Threaded TitaniumORTHO-DESIGN (PTY) LTD2023-12-07
06009712642748Anchor Threaded TitaniumORTHO-DESIGN (PTY) LTD2023-12-07
06009712642755Anchor Threaded TitaniumORTHO-DESIGN (PTY) LTD2023-12-07
06009712642762Anchor Threaded TitaniumORTHO-DESIGN (PTY) LTD2023-12-07
06009712642779Anchor Impact PEEKORTHO-DESIGN (PTY) LTD2023-12-07
06009712642786Anchor Threaded PEEKORTHO-DESIGN (PTY) LTD2023-12-07
06009712642793Anchor Threaded Titanium-PEEKORTHO-DESIGN (PTY) LTD2023-12-07
06009712642809Anchor Threaded Titanium-PEEKORTHO-DESIGN (PTY) LTD2023-12-07
06009712642816Anchor Threaded Titanium-PEEKORTHO-DESIGN (PTY) LTD2023-12-07
06009708899484VersaTiORTHO-DESIGN (PTY) LTD2023-09-01
06009712640584VersaTapORTHO-DESIGN (PTY) LTD2023-09-01
06009712640591VersaTapORTHO-DESIGN (PTY) LTD2023-09-01
06009712641611VersaTiORTHO-DESIGN (PTY) LTD2023-09-01
06009712641628VersaTiORTHO-DESIGN (PTY) LTD2023-09-01
06009712641635DueLockORTHO-DESIGN (PTY) LTD2023-09-01
06009712641642VersaTapORTHO-DESIGN (PTY) LTD2023-09-01
06009712641666MiniTiORTHO-DESIGN (PTY) LTD2023-09-01
06009712642250VersaPEEKORTHO-DESIGN (PTY) LTD2023-09-01
06009712641581VersaTapORTHO-DESIGN (PTY) LTD2023-08-31

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