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510(k) K972734

PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) by Mednet Locator, Inc. — Product Code ETB

K972734 is an FDA 510(k) premarket notification submitted by Mednet Locator, Inc. for the device "PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)". The FDA issued a decision of Substantially Equivalent on September 5, 1997. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Mednet Locator, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1997
Date Received
July 22, 1997
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 Mednet Locator, Inc.

  • 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)
  • K974174 — ULTRABUR (March 10, 1998)
  • K972735 — TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) (September 5, 1997)
  • K972737 — CAUSSE PISTON (September 5, 1997)
  • K972126 — MYRINGOTOMY TUBE (July 29, 1997)
  • K971943 — MYRINGOTOMY TUBE (July 23, 1997)
  • K972400 — MYRINGOTOMY TUBE - BOBBIN WITH TAB (July 23, 1997)

Other clearances for product code ETB

  • K260718 — mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (5 (April 3, 2026)
  • K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x (April 3, 2026)
  • 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)
  • K063374 — NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, (December 6, 2006)
  • K061853 — GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT (August 18, 2006)
  • K060518 — PARTIAL OSSICULAR REPLACEMENT PROSTHESES (June 28, 2006)

FDA data resources