OSBORN MEDICAL CORPORATION

FDA Device Registration & Listing · CENTENNIAL, CO, US · Registration 2184046

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2184046
FEI Number
1000115781
Entity Name
OSBORN MEDICAL CORPORATION
City/State/Country
CENTENNIAL, CO, US
Establishment Address
9750 E EASTER AVE STE 155, CENTENNIAL, CO 80112, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
OSBORN MEDICAL CORP. (Owner Number: 9004616)
Owner / Operator Contact Address
9750 E Easter Ave Suite 155, Centennial, CO 80112, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Rooke Soft AFO Rooke BKA Protector Rooke AKA Protector Rooke Classic Boot Rooke Vascular Boot Rooke Vascular Mitten Rooke Perioperative Boot Rooke Breeze Boot

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 1993-11-10
IPM Cover, Limb Physical Medicine Class 1 890.3025 1992-05-05
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 1992-11-27

Official Correspondent

Ian MacDonald

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OSBORN MEDICAL CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2184046. Last updated year: 2026. Please use registration number 2184046 when referencing this establishment in official correspondence.
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