510(k) K952697

TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM by Smith & Nephew Richards, Inc. — Product Code HWC

K952697 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on September 12, 1995. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1995
Date Received
June 13, 1995
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