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510(k) K052320

ENCORE CLP OFFSET TOTAL HIP SYSTEM by Encore Medical Corporation — Product Code KWA

K052320 is an FDA 510(k) premarket notification submitted by Encore Medical Corporation for the device "ENCORE CLP OFFSET TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on Dec 30, 2005. 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.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 30, 2005
Date Received
Aug 25, 2005
Clearance Type
Traditional
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

Other clearances for product code KWA

  • K122778 — PROFEMUR Z REVISION HIP STEM (Oct 11, 2012)
  • K121544 — DYNASTY BIOFOAM SHELL (Jul 30, 2012)
  • K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS (May 18, 2012)
  • K113322 — CONSERVE THIN SHELL (Feb 3, 2012)
  • K112080 — PRESERVE HIP STEM (Dec 28, 2011)
  • K112150 — PROFEMUR GLADIATOR HA HIP STEM (Nov 23, 2011)
  • K113019 — PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER (Nov 10, 2011)
  • K111910 — GLADIATOR HIP STEM (Oct 14, 2011)
  • K110836 — CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY (Oct 7, 2011)
  • K110400 — TAPERLOC COMPLETE MICROPLASTY STEM (Sep 30, 2011)

FDA data resources

Source: FDA 510(k) database entry for K052320. Report a data issue: hello@regdatalab.com.