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510(k) K091187

GRACE DYNAMIC TORP by Grace Medical, Inc. — Product Code ETA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2009
Date Received
April 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Replacement, Ossicular Prosthesis, Total
Device Class
Class II
Regulation Number
874.3495
Review Panel
EN
Submission Type

Other clearances by Grace Medical, Inc.

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  • K161376 — DragonFly Surgical Drill System (August 25, 2016)
  • K080070 — K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES (April 17, 2008)
  • K063374 — NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, (December 6, 2006)
  • 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 ETA

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  • K043375 — FISCH TITANIUM MIDDLE EAR PROSTHESES (January 24, 2005)
  • K042503 — KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM (October 1, 2004)
  • K030492 — TITANIUM OSSICULAR REPLACMENT SYSTEM (March 3, 2003)
  • K002378 — MODULAR PORP AND TORP MODEL TBD (August 29, 2000)
  • K001406 — HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES (August 8, 2000)
  • K001404 — GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GO (August 8, 2000)
  • K001902 — BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD (July 10, 2000)
  • K993583 — ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM (November 10, 1999)