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510(k) K051844

EQUATOR PLUS ACETABULAR CUP SYSTEM by Portland Orthopaedics Pty. , Ltd. — Product Code MAY

K051844 is an FDA 510(k) premarket notification submitted by Portland Orthopaedics Pty. , Ltd. for the device "EQUATOR PLUS ACETABULAR CUP SYSTEM". The FDA issued a decision of Substantially Equivalent on October 7, 2005. The device falls under product code MAY (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish), a Class II device regulated under 21 CFR 888.3353. Portland Orthopaedics Pty. , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2005
Date Received
July 7, 2005
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 Cemented, Osteophilic Finish
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Portland Orthopaedics Pty. , Ltd.

  • K061564 — PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD (September 1, 2006)
  • K053417 — M-COR HIP REPLACEMENT SYSTEM (July 20, 2006)
  • K032641 — MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM (January 20, 2004)
  • K992815 — THE MARGRON HIP REPLACEMENT SYSTEM (February 7, 2000)

Other clearances for product code MAY

  • K123604 — ABG III MONOLITHIC HIP STEM (August 16, 2013)
  • K110807 — ABG II MONOLITHIC HIP STEM (May 25, 2011)
  • K090103 — 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL (February 11, 2009)

FDA data resources