510(k) K113322

CONSERVE THIN SHELL by Wrightmedicaltechnologyinc — Product Code KWA

K113322 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "CONSERVE THIN SHELL". The FDA issued a decision of Substantially Equivalent on Feb 3, 2012. The device falls under product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3330. Wrightmedicaltechnologyinc has 301 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 3, 2012
Date Received
Nov 10, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3330
Review Panel
OR
Submission Type
PMA

Source: FDA 510(k) database entry for K113322. Report a data issue: hello@regdatalab.com.