Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006336810

FEI Number

3006336810

Entity Name

NYOrtho

City/State/Country

Brooklyn, NY, US

Establishment Address

63 Flushing Ave, Bldg 280, 7th Floor, Brooklyn, NY 11205, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

New York Orthopedic USA (Owner Number: 10040542)

Owner / Operator Contact Address

63 Flushing Ave, Building 280, 7th floor, Brooklyn, NY 11205, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NYOrtho NYOrtho Roll Control Bolster NYOrtho NYOrtho NYOrtho NYOrtho NYOrtho NYOrtho NYOrtho NYOrtho NYOrtho NYOrtho NYOrtho NYOrtho NYOrtho NYOrtho NYOrtho

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-11-20
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2022-12-28
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2022-12-28
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2020-09-02
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2022-12-28
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2014-05-14
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2015-06-29
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2022-12-28
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2012-10-16
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2014-05-22
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2014-03-27
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2022-11-20
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2022-12-28
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2014-05-15
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2017-05-14
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2015-02-05
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2012-04-23

Official Correspondent

Michael Rozenberg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

New York Orthopedic USA

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
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006336810. Last updated year: 2026. Please use registration number 3006336810 when referencing this establishment in official correspondence.