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510(k) K842234

NEW JERSEY FEMORAL STEM by Endomedics, Inc. — Product Code KWL

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, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Endomedics, Inc.

  • K831792 — SELF-ALIGNING ACETABULAR COMPONENT (September 20, 1984)
  • K842233 — NEW JERSEY FEMORAL RESURFACING COMPONENT (July 20, 1984)
  • K842202 — NEW JERSEY ACETABULAR COMPONENT & (July 20, 1984)

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