FDA 510(k) Application Details - K073349

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

  More FDA Info for this Device
510(K) Number K073349
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant Reliance Medical Systems, LLC
2647 CASSOWARY CIR
SANDY, UT 84092-7116 US
Other 510(k) Applications for this Company
Contact Bret M Berry
Other 510(k) Applications for this Contact
Regulation Number 888.3060

  More FDA Info for this Regulation Number
Classification Product Code KWQ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 11/29/2007
Decision Date 02/13/2008
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact