510(k) K092133

ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N by Arthrocare Corp. — Product Code HWC

K092133 is an FDA 510(k) premarket notification submitted by Arthrocare Corp. for the device "ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N". The FDA issued a decision of Substantially Equivalent on November 5, 2009. The device falls under product code HWC (Screw, Fixation, Bone), 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
November 5, 2009
Date Received
July 15, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type