Data / Medical devices / South Africa / Ortho-Design
Ortho-Design: FDA-registered device maker in Pretoria Gauteng, South Africa, 2 510(k) clearances
Ortho-Design is registered with the FDA (registration 3024856795) in Pretoria Gauteng, South Africa. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 29, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024856795
- Address
- 61 Thomas Edison Menly Park, Pretoria Gauteng, South Africa, 0081
- Owner or operator
- Ortho-Design (10086235)
- Roles
- Specification developer
- First device listed
- October 24, 2022
- Registered through
- 2026
- Brand names listed
- DoubleTap, DueLock, Free Needle, MicroTi, MiniTi, Nitinol Suture Feeder, OD Drill, OD Tap and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Specification developer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Specification developer | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 29, 2024 | K242296 | VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK) | MBI | Substantially Equivalent | Ortho-Design (Pty), Ltd. | accessdata.fda.gov |
| December 6, 2021 | K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | MBI | Substantially Equivalent | Ortho-Design (Pty), Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Bit, Drill
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Tap, Bone
- All makers of Accessories, Arthroscopic
- All makers of Needle, Suturing, Disposable
Updated August 29, 2024. 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.