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510(k) K030492

TITANIUM OSSICULAR REPLACMENT SYSTEM by Invotec International, Inc. — Product Code ETA

K030492 is an FDA 510(k) premarket notification submitted by Invotec International, Inc. for the device "TITANIUM OSSICULAR REPLACMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on March 3, 2003. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Invotec International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2003
Date Received
February 19, 2003
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 Invotec International, Inc.

  • K122040 — INVOTEC LARYNGEAL ELECTRODE (October 31, 2013)
  • K080740 — CLEARVIEW ENDOSCOPE COVER (December 31, 2008)
  • K973580 — INVOTEC CLEAN PAD (December 10, 1997)
  • K973578 — INVOTEC EAR TAMPON (WICK) W/STRING (November 6, 1997)
  • K971000 — EPISTAXIS NASAL PACK (May 14, 1997)
  • K930114 — TRACHEOSTOMY T-TUBE (March 19, 1993)
  • K911041 — INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE (June 4, 1991)
  • K911040 — INVOTEC MICROSCOPE DRAPE (June 3, 1991)
  • K911039 — INVOTEC EAR DRAPE (May 13, 1991)
  • K901923 — INVOTEC POLY-MESH MANDIBULAR TRAY (October 31, 1990)

Other clearances for product code ETA

  • K260719 — mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (5869 (April 3, 2026)
  • K241269 — mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO To (January 17, 2025)
  • K091187 — GRACE DYNAMIC TORP (September 14, 2009)
  • K083780 — SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL0 (March 23, 2009)
  • 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)
  • 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)

FDA data resources