Chrysalis Intelligence · Sponsors · Auxein Medical Private Limited

Auxein Medical Private Limited

Sonepat, IN · 12 510(k) clearances

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Total clearances
12
2020-06-10 → 2023-11-30
Last 12 months
0
Product codes
5
Most recent
2023-11-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HRS Plate, Fixation, Bone Class II Orthopedic 4 2023-01-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Class II Orthopedic 4 2022-12-16
HWC Screw, Fixation, Bone Class II Orthopedic 2 2021-08-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class II Orthopedic 1 2023-11-30
JDS Nail, Fixation, Bone Class II Orthopedic 1 2020-06-10
Filings

All 510(k) clearances (12)

Date K-number Device Code Class Specialty
2023-11-30 K221787 Auxein's DHS/DCS Plate System KTT Class II Orthopedic
2023-01-27 K213059 Tibia and Fibula System HRS Class II Orthopedic
2022-12-16 K213110 AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor MBI Class II Orthopedic
2022-11-18 K213018 Auxilock GFS Mini, GFS II Large, and GFS Ultimate MBI Class II Orthopedic
2022-11-04 K213108 Humerus & Ulna System HRS Class II Orthopedic
2022-10-03 K213014 Varixis Elbow System HRS Class II Orthopedic
2022-08-22 K213109 Auxilock Draw Tight Suture-Based Anchor MBI Class II Orthopedic
2022-07-29 K213104 Auxilock Titanium Screw-In Suture Anchor MBI Class II Orthopedic
2022-03-14 K211324 2.4mm Distal Radius System HRS Class II Orthopedic
2021-08-25 K210792 Auxein Nailing System HWC Class II Orthopedic
2021-08-20 K203029 Auxilock Titanium Interference Screw HWC Class II Orthopedic
2020-06-10 K192003 Auxein Nailing System JDS Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence