Home / 510(k) Clearances / K823442

510(k) K823442

FISCH MODIFIED TOTAL OSSICULAR PROSTHES by Treace Medical, Inc. — Product Code LBM

K823442 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "FISCH MODIFIED TOTAL OSSICULAR PROSTHES". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code LBM (Porous Polyethylene Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
November 16, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Porous Polyethylene Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
Review Panel
EN
Submission Type

Other clearances by Treace Medical, Inc.

  • K883727 — BUCKET PROSTHESIS PORP (January 13, 1989)
  • K882349 — MALLET, SURGICAL (June 23, 1988)
  • K874779 — BIPOLATOR 50 (January 29, 1988)
  • K873154 — TREACE MAGNUM OTO-TOOL SYSTEM (September 4, 1987)
  • K872000 — EYE GARD (July 21, 1987)
  • K870765 — CANNULATED INSTRUMENT CLEANERS (May 27, 1987)
  • K871706 — OPTHA PREP (May 18, 1987)
  • K870759 — CLEANING SOLUTION, CATALOG NO. 8203 (May 7, 1987)
  • K870766 — PROSTHESIS WIRE (April 15, 1987)
  • K870764 — SCHUKNECHT WIRE CUTTING SCISSORS (March 18, 1987)

Other clearances for product code LBM

  • K823441 — AUSTIN MODIFIED TOTAL OSSICULAR REPLACE (December 3, 1982)

FDA data resources