FDA Registration
Active
🇩🇪 Germany
Hoogland Spine Products GmbH
Reg #: 3006561161
·
FEI: 3006561161
·
Expires 2026
Products
33
Proprietary Names
18
Establishment Types
2
Classifications
33
Registration Details
- Registration Name
- Hoogland Spine Products GmbH
- Registration Number
- 3006561161
- FEI Number
- 3006561161
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Feringastr. 4
- City
- Unterfoehring Munich Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K193131
Owner / Operator
- Firm Name
- Hoogland Spine Products GmbH
- Operator Number
- 10023561
- Address
- Feringastr. 4
- City
- Unterfoehring Munich
- State
- Bavaria
- Postal Code
- 85774
- Country
- DE
- Correspondent
- Jaap Hoogland
US Agent
- Business Name
- QSR Consulting
- Contact Name
- Kenneth Kleinhenz
- Address
- 4141 Elm Rd.
- City
- Hudson
- State
- MI
- ZIP
- 49247
- Country
- US
- [email protected]
- Phone
- 619 2449573
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Cine, Endoscopic, Without Audio | FWL | Class 1 | General, Plastic Surgery | No | 2023-05-23 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2023-06-06 |
| Guide, Drill, Ligament | LXI | Class 1 | General, Plastic Surgery | No | 2017-11-23 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2017-11-23 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2007-12-03 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2007-12-03 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-07-28 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2007-12-03 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2017-11-23 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2007-12-03 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2021-07-14 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2021-07-14 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2007-12-03 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2007-12-03 |
| Probe | HXB | Class 1 | Orthopedic | No | 2009-02-10 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2007-12-03 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2007-12-03 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2008-07-29 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2008-07-29 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2018-01-16 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2007-12-03 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2007-12-03 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2011-03-17 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2017-11-23 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2021-07-21 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2017-11-23 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2021-07-14 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2007-12-03 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2008-08-29 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2007-12-03 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2007-12-03 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2007-12-03 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2021-07-14 |
Proprietary Names
maxmore Smart Pack System
BD Quincke Spinal Needle
MaxMore TOM painless hammer
maxMore bone drill manual
Sterile Spinal Needle - 18G
maxMore cleaning brush
maxMore metal ruler
Needle Placer
maxMore TOMshidi needle
sealing cap
maxMore TOM Stick Endoscope
Container small 1/2
maxMore dilator small
wrench
MaxMoreSpine TOM Stick
maxMore grasping forceps
maxMore instrument tray
maxMore abrasion device
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device