510(k) K172336

Smith & Nephew Patient Matched Cutting Blocks by Smith & Nephew, Inc. — Product Code JWH

K172336 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "Smith & Nephew Patient Matched Cutting Blocks". The FDA issued a decision of Substantially Equivalent on Jan 10, 2018. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 10, 2018
Date Received
Aug 2, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type
510(k)