OCI & Spinal devices’ International Quality accreditations
Ortho-Centric Innovations (Pty) Ltd., (OCI) is recognised and proudly approved as a manufacturer of Medical Devices by SAHPRA the South African regulatory authority.
In addition to the OCI ventures, the company intends having it’s newly designed devices tested in USA by fully accredited test houses.
Once these important tests are completed, the Master File will be completed and submitted by JALEX to the USA FDA for it’s approval of a 510K accreditation.
OCI intends achieving FDA status by end 2022 with an intended exhibit at NASS 2023 forming part of its international launch program.
Preparation of the Radical pedicle screw samples for testing is well underway and the Master File is 95% completed for FDA submission.
Once the Radical™ program is completed, the Statum™ interbody cages will be submitted for FDA 510K approvals.