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510(k) K842233

NEW JERSEY FEMORAL RESURFACING COMPONENT by Endomedics, Inc. — Product Code KXA

K842233 is an FDA 510(k) premarket notification submitted by Endomedics, Inc. for the device "NEW JERSEY FEMORAL RESURFACING COMPONENT". The FDA issued a decision of Substantially Equivalent on July 20, 1984. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Endomedics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1984
Date Received
June 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral, Resurfacing
Device Class
Class II
Regulation Number
888.3400
Review Panel
OR
Submission Type

Other clearances by Endomedics, Inc.

  • K831792 — SELF-ALIGNING ACETABULAR COMPONENT (September 20, 1984)
  • K842234 — NEW JERSEY FEMORAL STEM (July 20, 1984)
  • K842202 — NEW JERSEY ACETABULAR COMPONENT & (July 20, 1984)

Other clearances for product code KXA

  • K201219 — Biocore9 Femoral Head Resurfacing Component (January 19, 2021)
  • K092198 — CORMET CEMENTLESS RESURFACING FEMORAL HEAD (April 15, 2010)
  • K082673 — CONSERVE PRESSFIT FEMORAL COMPONENT (December 12, 2008)
  • K071053 — RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD (June 29, 2007)
  • K070292 — DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS (April 26, 2007)
  • K062960 — CONSERVE FEMORAL RESURFACING COMPONENT (December 1, 2006)
  • K043542 — BIOPRO TARA FEMORAL RESURFACING COMPONENT (May 18, 2005)
  • K032659 — DEPUY ASR RESURFACING FEMORAL HEADS (December 4, 2003)
  • K023188 — PRESS-FIT HEAD RESURFACING DEVICE (December 11, 2002)
  • K021549 — CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM (August 1, 2002)

FDA data resources