510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K163323Substantially Equivalent

Dolphix® External Fixation System MR Conditional

Citieffe Inc., Calderara Di Reno, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K163323 is the FDA 510(k) clearance record for Dolphix® External Fixation System MR Conditional, a class II device, cleared for Citieffe S.R.L. on under FDA product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component). FDA records list 11 510(k) clearances for Citieffe S.R.L., from to . As of , FDA records show no recalls naming K163323.

Clearance record

Decision date
Received
(115 days to decision)
Product code
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Citieffe S.R.L. Via Armaroli, 21, Calderara Di Reno, IT
510(k) summary
Statement
Third party review
No

Clearances, product code KTT

Trailing 12 months
8 clearances under product code KTT in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KTT, trailing twelve months
MonthClearances
November 20252
December 20252
January 20261
February 20260
March 20261
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260