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510(k) K955631

ORTHOPLUG HARD BONE DESIGN by Sunmed, Inc. — Product Code LZN

K955631 is an FDA 510(k) premarket notification submitted by Sunmed, Inc. for the device "ORTHOPLUG HARD BONE DESIGN". The FDA issued a decision of Substantially Equivalent on February 27, 1996. The device falls under product code LZN (Cement Obturator), a Class II device regulated under 21 CFR 878.3300. Sunmed, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1996
Date Received
December 11, 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 Sunmed, Inc.

  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K121743 — EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN (March 28, 2013)
  • K081805 — CUFFALERT (November 14, 2008)
  • K062112 — SUNMED FOLEY CATHETERS (June 4, 2007)
  • K955632 — ORTHOPLUG SOFT BONE DESIGN (February 27, 1996)
  • K921263 — SUNLITE LARYNGOSCOPE (June 1, 1993)

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