510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K992403Substantially Equivalent

Mrp-Titan

Rotec Medizintechnik GmbH, Weisendorf, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992403 is the FDA 510(k) clearance record for MRP-TITAN, a class II device, cleared for Rotec Medizintechnik GmbH on under FDA product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented). FDA records list 2 510(k) clearances for Rotec Medizintechnik GmbH, from to . As of , FDA records show no recalls naming K992403.

Clearance record

Decision date
Received
(186 days to decision)
Product code
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Rotec Medizintechnik GmbH Am Muhlberg 31, Weisendorf, DE
510(k) summary
Summary
Third party review
No

Clearances, product code LZO

Trailing 12 months
9 clearances under product code LZO in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LZO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20262
April 20261
May 20260
June 20261
July 20261
August 20260
September 20262
October 20261