Data / Medical devices / South Africa / Titamed
Titamed: FDA-registered device maker in Cape Town Western Cape, South Africa, 1 510(k) clearance
Titamed is registered with the FDA (registration 3008754074) in Cape Town Western Cape, South Africa. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 31, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008754074
- Address
- 54 Auckland Street Paarden Eiland, Cape Town Western Cape, South Africa, 7405
- Owner or operator
- TiTaMED (10034639)
- Roles
- Manufacturer
- First device listed
- December 20, 2010
- Registered through
- 2026
- Brand names listed
- Ti-TaMED Spinal System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2009 | K070385 | TI-TAMED SPINAL SYSTEM | NKB | Substantially Equivalent | Ti-Tamed (Pty), Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
Updated July 31, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.