The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000.
| Device ID | K211490 |
| 510k Number | K211490 |
| Device Name: | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | Stryker Corporation 4100 East Milham Avenue Kalamazoo, MI 49001 |
| Contact | John Chesney |
| Correspondent | John Chesney Stryker Corporation 4100 East Milham Avenue Kalamazoo, MI 49001 |
| Product Code | ERL |
| Subsequent Product Code | DZJ |
| Subsequent Product Code | HBE |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-13 |
| Decision Date | 2021-06-09 |