Thompson Surgical Instruments, Inc.
Traverse City, MI, US
THOMPSON SURGICAL INSTRUMENTS, INC. appears in FDA device records in Traverse City, MI. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Thompson Surgical Instruments, Inc. between 2008 and 2022. The busiest year on record is 2008, with 1. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2015 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) | GZT | Substantially Equivalent | |
| K151347 | MIS Spine Frame Instrument Case | KCT | Substantially Equivalent | |
| K080962 | LITE WAND II | FST | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1450428 | 1450428 | THOMPSON SURGICAL INSTRUMENTS, INC. | 10341 EAST CHERRY BEND RD., TRAVERSE CITY, MI 49684 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QLVField Generator Positioning Device
- FZXGuide, Surgical, Instrument
- DWSInstruments, Surgical, Cardiovascular
- FSXLight, Surgical, Connector
- FSTLight, Surgical, Fiberoptic
- LXHOrthopedic Manual Surgical Instrument
- GADRetractor
- GZTRetractor, Self-Retaining, For Neurosurgery
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- BWNTable And Attachments, Operating-Room
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain