Data / Medical devices / United States / Thompson Surgical Instruments, Inc.
Thompson Surgical Instruments, Inc.: FDA-registered device maker in Traverse City, MI, United States, 2 510(k) clearances
Thompson Surgical Instruments, Inc. is registered with the FDA (registration 1450428) in Traverse City, MI, United States. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 13, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1450428
- Address
- 10341 East Cherry Bend RD., Traverse City, MI, United States, 49684
- Owner or operator
- THOMPSON SURGICAL INSTRUMENTS, INC. (1450428)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 22, 1992
- Registered through
- 2026
- Brand names listed
- 0701106001 - 60MM, MIS RETRACTOR ASSY, 0701106002 - 70MM, MIS RETRACTOR ASSY, 0701106003 - 80MM, MIS RETRACTOR ASSY, 0701106004 - 100MM, MIS RETRACTOR ASSY, 0701107001 - RTR GUIDE, MIS RETRACTOR, 0701117001 - MIS RET. EXPANDER ASSY, 0701127001 - RAIL CLAMP, 0701128001 - JACKSON TABLE ADAPTER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Field Generator Positioning Device | QLV | 1 | Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Contract manufacturer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Light, Surgical, Connector | FSX | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor, Ent | KAL | 1 | Manufacturer | accessdata.fda.gov |
| Retractor, Self-Retaining, For Neurosurgery | GZT | 2 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Table And Attachments, Operating-Room | BWN | 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 |
|---|---|---|---|---|---|---|
| May 13, 2022 | K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) | GZT | Substantially Equivalent | Thompson Surgical Instruments, Inc. | accessdata.fda.gov |
| October 16, 2015 | K151347 | MIS Spine Frame Instrument Case | KCT | Substantially Equivalent | Thompson Surgical Instruments | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Guide, Surgical, Instrument
- All makers of Retractor
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Light, Surgical, Connector
- All makers of Instruments, Surgical, Cardiovascular
Updated May 13, 2022. 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.