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510(k) K883794

RESUBMITTED CLW ACETABULAR CUP W/SULMESH by Protek, Inc. — Product Code LWJ

K883794 is an FDA 510(k) premarket notification submitted by Protek, Inc. for the device "RESUBMITTED CLW ACETABULAR CUP W/SULMESH". The FDA issued a decision of Substantially Equivalent on May 26, 1989. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Protek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1989
Date Received
September 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3360
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)
  • 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)
  • K874093 — SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP (January 27, 1988)

Other clearances for product code LWJ

  • K120595 — UNISYN PLUS HIP STEM (October 12, 2012)
  • K103518 — TRINITY ACETABULAR SYSTEM (March 9, 2011)
  • K090764 — NOVATION CFS PRESS-FIT AND CEMENTED STEMS (April 21, 2009)
  • K082146 — METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD (September 9, 2008)
  • K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT (January 31, 2007)
  • K062978 — U2 HIP STEM, TI PLASMA SPRAY (January 16, 2007)
  • K062383 — UNISYN HA PLASMA MODULAR HIP (December 21, 2006)
  • K061699 — EXCIA (August 18, 2006)
  • K051826 — BETACONE HIP PROSTHESIS SYSTEM (November 18, 2005)
  • K050262 — U2 ACETABULAR COMPONENT (August 15, 2005)

FDA data resources