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

Sonipat, IN

Auxein medical Private limited appears in FDA device records in Sonipat, IN. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
12
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 12 510(k) clearances for Auxein medical Private Limited between 2020 and 2023. The busiest year on record is 2022, with 7. The most recent is 2023, with 2.

Clearances by year, as a table
510(k) clearance decisions for Auxein medical Private Limited, by decision year
YearClearances
20201
20212
20227
20232
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K221787Auxein's DHS/DCS Plate SystemKTTSubstantially Equivalent
K213059Tibia and Fibula SystemHRSSubstantially Equivalent
K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorMBISubstantially Equivalent
K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateMBISubstantially Equivalent
K213108Humerus & Ulna SystemHRSSubstantially Equivalent
K213014Varixis Elbow SystemHRSSubstantially Equivalent
K213109Auxilock Draw Tight Suture-Based AnchorMBISubstantially Equivalent
K213104Auxilock Titanium Screw-In Suture AnchorMBISubstantially Equivalent
K2113242.4mm Distal Radius SystemHRSSubstantially Equivalent
K210792Auxein Nailing SystemHWCSubstantially Equivalent
K203029Auxilock Titanium Interference ScrewHWCSubstantially Equivalent
K192003Auxein Nailing SystemJDSSubstantially Equivalent

Registered establishments

FDA registered establishments for Auxein medical Private Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30103030973010303097Auxein medical Private limitedPlot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area,, Sonipat Haryana 131028 IN2026and 73 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain