Home / 510(k) Clearances / K955751

510(k) K955751

PRIME FEMORAL CEMENT PLUG by Orthopaedic Innovations, Inc. — Product Code LZN

K955751 is an FDA 510(k) premarket notification submitted by Orthopaedic Innovations, Inc. for the device "PRIME FEMORAL CEMENT PLUG". The FDA issued a decision of Substantially Equivalent on January 26, 1996. The device falls under product code LZN (Cement Obturator), a Class II device regulated under 21 CFR 878.3300. Orthopaedic Innovations, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1996
Date Received
December 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement Obturator
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

Other clearances by Orthopaedic Innovations, Inc.

  • K020145 — ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM (April 15, 2002)
  • K983881 — COBRA EXTERNAL FIXATOR (December 4, 1998)
  • K962646 — PRIME MODULAR ENDO HEAD (September 23, 1996)
  • K960014 — PRACTIFIX EXTERNAL FIXATION SYSTEM (March 18, 1996)
  • K955620 — PRIME CEMENTED CALCAR FEMORAL STEMS (February 20, 1996)
  • K953033 — PRIME CEMENTED SMALL FEMORAL STEM (September 13, 1995)
  • K940328 — PRIME CEMENTED HIP SYSTEM (April 7, 1995)

Other clearances for product code LZN

  • K220838 — Artisan Bone Plug, Universal Cement Restrictor (May 20, 2022)
  • K061824 — TORNIER CEMENT RESTRICTOR (September 14, 2006)
  • K032685 — CEMSTOP CEMENT RESTRICTOR (November 26, 2003)
  • K023680 — BIOBUCK CEMENT RESTRICTOR (November 19, 2002)
  • K011943 — IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR (September 19, 2001)
  • K010840 — SYNPLUG (April 20, 2001)
  • K000587 — SHUTTLE STOP (May 4, 2000)
  • K993841 — CEMSTOP CEMENT RESTRICTOR (May 4, 2000)
  • K992462 — OSTEONICS UNIVERSAL DISTAL CEMENT PLUG (August 13, 1999)
  • K972411 — LINK CEMENT PLUG (August 29, 1997)

FDA data resources