Data / Medical devices / United Kingdom / Summit Medical Ltd.
Summit Medical Ltd.: FDA-registered device maker in Gloucestershire, United Kingdom, 1 510(k) clearance
Summit Medical Ltd. is registered with the FDA (registration 9617155) in Gloucestershire, United Kingdom. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 25, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9617155
- FEI number
- 1000345108
- Address
- Industrial Park Bourton On The Water, Gloucestershire, United Kingdom, GL54 2HQ
- Owner or operator
- SUMMIT MEDICAL LTD. (9027741)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- September 5, 1996
- Registered through
- 2026
- Brand names listed
- 6mm Slim Flexible Nozzle 414705, 9mm Nozzle with Nozzle Extruder, ANCHORMAN Tibial Ligament Fixation Device, ANCHORMAN Tibial Template, Bone Cement Delivery Gun H719, Bone Cement Delivery Gun H759, Bone Cement Delivery Gun H759L, Canulated Drill and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Curette | HTF | 1 | Manufacturer | accessdata.fda.gov |
| Dispenser, Cement | KIH | 1 | Manufacturer | accessdata.fda.gov |
| Evacuator, Vapor, Cement Monomer | JDY | 1 | Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | 1 | Exporter to the US | accessdata.fda.gov |
| Instrument, Surgical, Sonic And Accessory/Attachment | JDX | 2 | Exporter to the US | accessdata.fda.gov |
| Mixer, Cement, For Clinical Use | JDZ | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2017 | K170388 | ANCHORMAN Tibial Ligament Fixation Device | MBI | Substantially Equivalent | Summit Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Curette
- All makers of Instrument, Compression
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Instrument, Surgical, Sonic And Accessory/Attachment
- All makers of Dispenser, Cement
- All makers of Mixer, Cement, For Clinical Use
Updated July 25, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.