FDA 510(k) Application Details - K180227

Device Classification Name	More FDA Info for this Device
510(K) Number	K180227
Device Name	Polaris Spinal Growth System
Applicant	Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 US Other 510(k) Applications for this Company
Contact	Anthony Michael Maahs Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2018
Decision Date	03/15/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review