Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005663580

FEI Number

3005663580

Entity Name

MD ORTHOPAEDICS

City/State/Country

Wayland, IA, US

Establishment Address

604 NORTH PARKWAY ST, Wayland, IA 52654, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MD Orthopaedics, Inc. (Owner Number: 9083122)

Owner / Operator Contact Address

604 NORTH PARKWAY ST, --, Wayland, IA 52654, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rhino Ponseti® Plus Abduction Bar Ponseti® Lite Abduction Bar Mitchell Ponseti® Move Bar PONSETI Bar Rhino Rhino Unilateral Brace Shoe Adapter Ponseti® Ankle Foot Orthosis AFO Ponseti® Lite Boots Shoe Accessories Rhino Rhino

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2023-12-13
ITN	Splint, Denis Brown	Physical Medicine	Class 1	890.3675	2006-02-16
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2023-12-13
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2023-12-13
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2019-09-05
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2006-02-16
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2023-12-13
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2023-12-13

Official Correspondent

Yan Li

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MD Orthopaedics, Inc.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
2242467	HAUSMANN ENTERPRISES, LLC	NORTHVALE, NJ, US
8022890	VALENTINE INTL. LTD.	HSICHIH CITY, TAIPEI HSIEN, TW
3014982318	HONG MING ENTERPRISE CO., LTD.	Taichung City, TW
3027500264	BREG MEXICO, S. DE R.L. DE C.V. (4)	Mexicali Baja California, MX
3005533873	SUZHOU SUNMED CO., LTD	SUZHOU CITY Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005663580. Last updated year: 2026. Please use registration number 3005663580 when referencing this establishment in official correspondence.