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510(k) K831792

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

K831792 is an FDA 510(k) premarket notification submitted by Endomedics, Inc. for the device "SELF-ALIGNING ACETABULAR COMPONENT". The FDA issued a decision of Substantially Equivalent on September 20, 1984. The device falls under product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3320. Endomedics, Inc. has at least 3 other 510(k) clearances on record.

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)

Other clearances for product code JDL

  • K073499 — VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES (August 7, 2008)
  • 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)

FDA data resources