510(k) K950999

KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS by Buckman Co., Inc. — Product Code MNH

K950999 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS". The FDA issued a decision of Substantially Equivalent on January 25, 1996. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1996
Date Received
March 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type