510(k) K954696

ROGOZINSKI THORACOLUMBAR SPINAL ROD by Smith & Nephew Richards, Inc. — Product Code KWP

K954696 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "ROGOZINSKI THORACOLUMBAR SPINAL ROD". The FDA issued a decision of SN on March 11, 1996. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 11, 1996
Date Received
October 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type