FDA Registration
Active
🇬🇧 United Kingdom
SUMMIT MEDICAL LTD.
Reg #: 9617155
·
FEI: 1000345108
·
Expires 2026
Products
8
Proprietary Names
25
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- SUMMIT MEDICAL LTD.
- Registration Number
- 9617155
- FEI Number
- 1000345108
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- INDUSTRIAL PARK, BOURTON ON THE WATER
- City
- GLOUCESTERSHIRE
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K170388
Owner / Operator
- Firm Name
- SUMMIT MEDICAL LTD.
- Operator Number
- 9027741
- Address
- INDUSTRIAL PARK, BOURTON ON THE WATER
- City
- GLOUCESTERSHIRE
- State
- GB-NOTA
- Postal Code
- GL54 2HQ
- Country
- GB
- Correspondent
- Liz - Hayward
US Agent
- Business Name
- Dawa Medical LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 NW 12th Street, Suite 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 305 5999373
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 1996-09-05 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 1999-03-19 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2023-06-23 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2021-08-26 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2017-07-26 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2020-02-18 |
| Evacuator, Vapor, Cement Monomer | JDY | Class 1 | Orthopedic | No | 2008-12-03 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2008-12-03 |
Proprietary Names
HiVac Syringe
9mm Nozzle with Nozzle Extruder
MiniMix Delivery Syringe SMDS1C
HIVAC 7 Triple Mix C703
ClearMix Triple Vacuum Mixing System 414703
ClearMix Vacuum Mixing System 414701
Cement Mixing and Delivery System - 00-4501-090-00
ClearMix Bone Cement Mixing and Delivery System 414702
HiVac7 with Femoral Cement Pressuriser CP701
6mm Slim Flexible Nozzle 414705
HiVac 7 Bone Cement Mixing and Delivery System - C701
Quick-Vac Vacuum Mixing Bowl
MiniMix LV SMLV
MiniMix SMMM1
HiVac Bowl B713
Mixing Bowl, Spatula B710
Disposable Surgical Lavage Systems
Femoral Cement Pressuriser P721
ANCHORMAN Tibial Ligament Fixation Device
High Vacuum Footpump
Bone Cement Delivery Gun H759L
Bone Cement Delivery Gun H759
ANCHORMAN Tibial Template
Bone Cement Delivery Gun H719
ClearMix Vacuum Mixing System Bone Cement Delivery Gun
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device