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510(k) K951934

PFC CEMENT RESTRICTOR by Johnson & Johnson Professionals, Inc. — Product Code LZN

K951934 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "PFC CEMENT RESTRICTOR". The FDA issued a decision of SN on May 16, 1995. The device falls under product code LZN (Cement Obturator), a Class II device regulated under 21 CFR 878.3300. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
May 16, 1995
Date Received
April 25, 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 Johnson & Johnson Professionals, Inc.

  • K992173 — SIPHONGUARD CSF CONTROL DEVICE (April 7, 2000)
  • K991413 — CODMAN ETHISORB DURA PATCH (March 13, 2000)
  • K991222 — CODMAN MICROSENSOR VENTRICULAR CATHETER KIT (July 9, 1999)
  • K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER (December 18, 1998)
  • K982812 — G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) (December 4, 1998)
  • K983141 — CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS (November 6, 1998)
  • K983014 — SUMMIT ACETABULAR SYSTEM (October 27, 1998)
  • K980778 — HAKIM MICRO PROGRAMMABLE VALVE SYSTEM (July 17, 1998)
  • K974739 — HAKIM PROGRAMMABLE VALVE SYSTEM (July 1, 1998)
  • K980801 — J-FX BIPOLAR HEAD (May 29, 1998)

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)
  • K993841 — CEMSTOP CEMENT RESTRICTOR (May 4, 2000)
  • K000587 — SHUTTLE STOP (May 4, 2000)
  • K992462 — OSTEONICS UNIVERSAL DISTAL CEMENT PLUG (August 13, 1999)
  • K972411 — LINK CEMENT PLUG (August 29, 1997)

FDA data resources