510(k) K123924

DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS by Depuy Orthopaedics — Product Code LZO

K123924 is an FDA 510(k) premarket notification submitted by Depuy Orthopaedics for the device "DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS". The FDA issued a decision of Substantially Equivalent on March 1, 2013. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Depuy Orthopaedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2013
Date Received
December 20, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type