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510(k) K870922

C.L.E. ACETABULAR CUP by Protek, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1987
Date Received
March 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Protek, Inc.

  • K893785 — ARC-2F ACETABULAR CUP (August 9, 1989)
  • K893959 — P.S.A. FEMORAL HIP PROSTHESIS (July 25, 1989)
  • K892059 — FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR (July 19, 1989)
  • K883794 — RESUBMITTED CLW ACETABULAR CUP W/SULMESH (May 26, 1989)
  • K884952 — VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC (May 10, 1989)
  • K884889 — MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. (February 27, 1989)
  • K890054 — M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. (February 8, 1989)
  • K884789 — NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI (February 8, 1989)
  • K884888 — MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS (December 29, 1988)
  • K882671 — SAMUELSON SCREWLOC CUP (October 20, 1988)

Other clearances for product code JDI

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  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
  • K220216 — C-Stem AMT LE Prosthesis (July 22, 2022)
  • K213701 — Exeter® X3® RimFit® Cup (February 1, 2022)
  • K213816 — MPO Hip Instruments (January 5, 2022)
  • K210842 — VerSys Cemented Revision/Calcar (December 10, 2021)