510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192003Substantially Equivalent

Auxein Nailing System

Auxein medical Private Limited, Sonipat, IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192003 is the FDA 510(k) clearance record for Auxein Nailing System, a class II device, cleared for Auxein Medical Private Limited on under FDA product code JDS (Nail, Fixation, Bone). FDA records list 12 510(k) clearances for Auxein Medical Private Limited, from to . As of , FDA records show no recalls naming K192003.

Clearance record

Decision date
Received
(320 days to decision)
Product code
JDS Nail, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Auxein Medical Private Limited Plot #168,169,170, Phase-Iv, Sector 57, Kundli Industrial, Sonipat, IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDS

Trailing 12 months

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

FDA records show no clearances under product code JDS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDS, 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