FDA 510(k) Application Details - K955927

Device Classification Name Appliance, Fixation, Spinal Interlaminal

  More FDA Info for this Device
510(K) Number K955927
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant ARCAN ORTHOPAEDIC CORP.
3903 HARRISON BLVD.
SUITE 400-E
OGDEN, UT 84403 US
Other 510(k) Applications for this Company
Contact DONALD W BRYAN
Other 510(k) Applications for this Contact
Regulation Number 888.3050

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

  More FDA Info for this Product Code
Date Received 12/22/1995
Decision Date 03/13/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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