Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024856795

FEI Number

3024856795

Entity Name

ORTHO-DESIGN

City/State/Country

Pretoria Gauteng, ZA

Establishment Address

61 Thomas Edison, Menly Park, Pretoria Gauteng 0081, ZA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Ortho-Design (Owner Number: 10086235)

Owner / Operator Contact Address

61 Thomas Edison Street, Menlo Park, Pretoria, ZA-GT 0081, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OD Drill DoubleTap OD Tap DoubleTap MiniTi VersaTi VersaLat-ST VersaLat VersaTap DueLock VersaTi Drill Nitinol Suture Feeder QuickFire Needle Free Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-03-19
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2023-09-05
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-10-24
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2023-09-05
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2023-09-05
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-03-19

Official Correspondent

Dian Peach

US Agent Details

Chhavy Tep-Cullison Business: Jalex Medical Email: ccullison@jalexmedical.com Phone: (440) 5410060

Related Public Records

Same Entity

Ortho-Design

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
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3038207124	NATIVE ORTHOPAEDICS	Providence, RI, US
3027516563	STAR SPORTS MEDICINE CO., LTD.	Beijing, CN
3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024856795. Last updated year: 2026. Please use registration number 3024856795 when referencing this establishment in official correspondence.