Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009227834

FEI Number

3009227834

Entity Name

ROG SPORTS MEDICINE, INC.

City/State/Country

Orland Park, IL, US

Establishment Address

16450 104th Ave, Orland Park, IL 60467, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

RoG Sports Medicine, Inc (Owner Number: 10037806)

Owner / Operator Contact Address

16450 104th ave, Orland Park, IL 60467, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111590

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-12-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-12-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-03-02
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2011-08-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-03-02
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2023-01-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-03-02

Official Correspondent

Josh Weil

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RoG Sports Medicine, Inc

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
1000200989	Paragon Medical - Dayton	Dayton, OH, US
1058584	Sterigenics US LLC	Charlotte, NC, US
1020279	SMITH & NEPHEW, INC.	MEMPHIS, TN, US
1625507	MEDTRONIC POWERED SURGICAL SOLUTIONS	FORT WORTH, TX, US
2648666	STRYKER PUERTO RICO, LLC.	ARROYO, PR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009227834. Last updated year: 2026. Please use registration number 3009227834 when referencing this establishment in official correspondence.