510(k) K102262

ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL by Arthrocare Corp. — Product Code MBI

K102262 is an FDA 510(k) premarket notification submitted by Arthrocare Corp. for the device "ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL". The FDA issued a decision of Substantially Equivalent on October 21, 2010. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Arthrocare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2010
Date Received
August 10, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type