The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Elite Attachments, Stryker Heavy Duty (hd) Attachments.
| Device ID | K143320 |
| 510k Number | K143320 |
| Device Name: | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Brittney M. Larsen |
| Correspondent | Brittney M. Larsen STRYKER CORP. 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 | 2014-11-19 |
| Decision Date | 2015-04-23 |
| Summary: | summary |