FDA 510(k) Application Details - K070227

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

  More FDA Info for this Device
510(K) Number K070227
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant ARTHROCARE CORP.
15285 ALTON PARKWAY
SUITE 200
IRVINE, CA 92618 US
Other 510(k) Applications for this Company
Contact LAURA N KASPEROWICZ
Other 510(k) Applications for this Contact
Regulation Number 888.3040

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

  More FDA Info for this Product Code
Date Received 01/24/2007
Decision Date 04/16/2007
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