The following data is part of a premarket notification filed by Thompson Surgical Instruments with the FDA for Mis Spine Frame Instrument Case.
| Device ID | K151347 |
| 510k Number | K151347 |
| Device Name: | MIS Spine Frame Instrument Case |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | THOMPSON SURGICAL INSTRUMENTS 10170 E CHERRY BEND RD Traverse City, MI 49684 |
| Contact | Stephanie Myers |
| Correspondent | Stephanie Myers THOMPSON SURGICAL INSTRUMENTS 10170 E CHERRY BEND RD Traverse City, MI 49684 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-20 |
| Decision Date | 2015-10-16 |
| Summary: | summary |