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510(k) K831792

SELF-ALIGNING ACETABULAR COMPONENT by Endomedics, Inc. — Product Code JDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1984
Date Received
June 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3320
Review Panel
OR
Submission Type

Other clearances by Endomedics, Inc.

  • K842234 — NEW JERSEY FEMORAL STEM (July 20, 1984)
  • K842233 — NEW JERSEY FEMORAL RESURFACING COMPONENT (July 20, 1984)
  • K842202 — NEW JERSEY ACETABULAR COMPONENT & (July 20, 1984)

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  • K070785 — DYNASTY ACETABULAR SYSTEM (July 11, 2007)
  • K061844 — DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER (December 6, 2006)
  • K051995 — PROFEMUR RENAISSANCE HIP STEM (August 22, 2005)
  • K051348 — CONSERVE TOTAL FEMORAL HEAD (August 19, 2005)
  • K042841 — M2A/C2A ACETABULAR SYSTEM (December 21, 2004)
  • K041586 — PROFEMUR S HIP STEM (July 9, 2004)
  • K041114 — PROFEMUR TAPERED HIP STEM (May 28, 2004)
  • K004043 — METAL TRANSCEND ARTICULATION SYSTEM (July 13, 2001)
  • K950542 — METAL BACKED ACETABULAR COMPONENT (May 25, 1995)