510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990345Unknown

Rabea Device, Model Pxxxxxx

Signus Medizintechnik GmbH, Shorewood MN / Traditional, Unknown
FDA source (opens on fda.gov)

K990345 is the FDA 510(k) clearance record for RABEA DEVICE, MODEL PXXXXXX, a class II device, cleared for Signus Medizintechnik GmbH on under FDA product code JDK (Prosthesis, Hip, Cement Restrictor). FDA records list 24 510(k) clearances for Signus Medizintechnik GmbH, from to . As of , FDA records show no recalls naming K990345.

Clearance record

Decision date
Received
(176 days to decision)
Product code
JDK Prosthesis, Hip, Cement Restrictor
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Signus Medizintechnik GmbH 27660 Woodside Rd., Shorewood MN
510(k) summary
Summary
Third party review
No

Clearances, product code JDK

Trailing 12 months

FDA records hold no clearances under product code JDK in the trailing twelve months.

FDA records show no clearances under product code JDK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260