# Summit Medical Ltd. (foreign exporter, Gloucestershire, GB): 2 new FDA device listings, incl. instrument, surgical, orthopedic, pneumatic powered & accessory/attach

**Score:** 40/100

| Field | Value |
|---|---|
| Establishment | Summit Medical Ltd. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Gloucestershire, GB |
| New listings | 2 |
| Devices | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Instrument, Surgical, Sonic And Accessory/Attachment |
| Product codes | HSZ, JDX |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery, Orthopedic |
| Brand names | Chisel long neg. gouge tip, curved dia. 4 /270mm; Srewdriver tip dia. 5 mm, 120 mm; Long neg. hollow tip dia. 3.2 mm, 270 mm; Foot pedal; SteriTray chisels set; Chisel long pos. gouge tip, curved dia. 4 /270mm; Handpiece Tube; Flexible microstructure chisel -single use- 190mm - 7 mm |
| First new listing | 2026-09-10 |
| Latest new listing | 2026-09-18 |
| FDA registration number | 9617155 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.