510(k) K882072

ORTHOPAEDIC AND SPINAL RING CURRETTES by Karlin Technology, Inc. — Product Code JXH

K882072 is an FDA 510(k) premarket notification submitted by Karlin Technology, Inc. for the device "ORTHOPAEDIC AND SPINAL RING CURRETTES". The FDA issued a decision of Substantially Equivalent on June 17, 1988. The device falls under product code JXH (Methyl Methacrylate For Aneurysmorrhaphy), a Class II device regulated under 21 CFR 882.5030. Karlin Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1988
Date Received
May 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Methacrylate For Aneurysmorrhaphy
Device Class
Class II
Regulation Number
882.5030
Review Panel
NE
Submission Type