510(k) K945182

DYONICS FIXATION SCREWS by Smith & Nephew Dyonics, Inc. — Product Code HWC

K945182 is an FDA 510(k) premarket notification submitted by Smith & Nephew Dyonics, Inc. for the device "DYONICS FIXATION SCREWS". The FDA issued a decision of SN on January 24, 1995. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew Dyonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
January 24, 1995
Date Received
October 24, 1994
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