510(k) K211490

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 by Stryker Corporation — Product Code ERL

K211490 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000". The FDA issued a decision of Substantially Equivalent on June 9, 2021. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. Stryker Corporation has at least 10 other 510(k) clearances on record.