510(k) K931737

HEDLEYL INTRAMEDULLARY PREPARATION BRUSH by Synvasive Technology, Inc. — Product Code HTZ

K931737 is an FDA 510(k) premarket notification submitted by Synvasive Technology, Inc. for the device "HEDLEYL INTRAMEDULLARY PREPARATION BRUSH". The FDA issued a decision of Substantially Equivalent on January 7, 1994. The device falls under product code HTZ (Instrument, Cutting, Orthopedic), a Class I device regulated under 21 CFR 878.4800. Synvasive Technology, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1994
Date Received
April 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cutting, Orthopedic
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type