The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Mis And Footed Attachments.
| Device ID | K191049 |
| 510k Number | K191049 |
| Device Name: | Stryker MIS And Footed Attachments |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | Stryker Corporation 4100 E Milham Ave Kalamazoo, MI 49001 |
| Contact | Paminder Khurmi |
| Correspondent | Paminder Khurmi Stryker Corporation 4100 E Milham Ave Kalamazoo, MI 49001 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-19 |
| Decision Date | 2019-06-18 |