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510(k) K063374

NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE by Grace Medical, Inc. — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2006
Date Received
November 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
Review Panel
EN
Submission Type

Other clearances by Grace Medical, Inc.

  • K232059 — Tympanostomy Tubes (November 24, 2023)
  • K161376 — DragonFly Surgical Drill System (August 25, 2016)
  • K091187 — GRACE DYNAMIC TORP (September 14, 2009)
  • K080070 — K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES (April 17, 2008)
  • K062672 — GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES (October 24, 2006)
  • K062385 — BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES (September 27, 2006)
  • K061853 — GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT (August 18, 2006)
  • K060518 — PARTIAL OSSICULAR REPLACEMENT PROSTHESES (June 28, 2006)
  • K991394 — STAPES PROSTHESES (May 18, 1999)
  • K981575 — TYMPANOSTOMY TUBE (July 15, 1998)

Other clearances for product code ETB

  • K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis (January 17, 2025)
  • K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFI (January 17, 2025)
  • K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES P (December 2, 2013)
  • K112616 — NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS (February 8, 2013)
  • K080070 — K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES (April 17, 2008)
  • K061853 — GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT (August 18, 2006)
  • K060518 — PARTIAL OSSICULAR REPLACEMENT PROSTHESES (June 28, 2006)
  • K033554 — SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS (November 24, 2003)
  • K021479 — CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 (May 21, 2002)
  • K013573 — CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 (November 9, 2001)