FDA Registration
Active
🇺🇸 United States
NYOrtho
Reg #: 3006336810
·
FEI: 3006336810
·
Expires 2026
Products
22
Proprietary Names
2
Establishment Types
3
Classifications
22
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Registration Details
- Registration Name
- NYOrtho
- Registration Number
- 3006336810
- FEI Number
- 3006336810
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 63 Flushing Ave, Bldg 280, 7th Floor
- City
- Brooklyn
- State
- NY
- ZIP
- 11205
- Country
- US
Owner / Operator
- Firm Name
- New York Orthopedic USA
- Operator Number
- 10040542
- Address
- 63 Flushing Ave, Building 280, 7th floor
- City
- Brooklyn
- State
- NY
- Postal Code
- 11205
- Country
- US
- Correspondent
- Michael Rozenberg
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2022-11-20 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2022-12-28 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2022-12-28 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2020-09-02 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2022-12-28 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2014-05-14 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2015-06-29 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2022-12-28 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2012-10-16 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2014-05-22 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2014-03-27 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2022-11-20 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2022-12-28 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2014-05-15 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2017-05-14 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2015-02-05 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2012-04-23 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2022-12-28 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2021-11-23 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2022-12-28 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2022-12-28 |
| Footrest, Wheelchair | IMM | Class 1 | Physical Medicine | No | 2014-05-14 |
Proprietary Names
NYOrtho
NYOrtho Roll Control Bolster
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility