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Auxein medical Private limited

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103030973010303097Auxein medical Private limited1N2026-01-01Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area, HSIIDC Sonipat- 131028, Haryana, INDIA Sonipat Haryana IN 131028

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08903993114377Expert Tibia Nail, Ø8mm x Length 255mm, Titanium, Sterile - TI-520-08-255-S9910643638info@auxein.com
08903993114384Expert Tibia Nail, Ø8mm x Length 270mm, Titanium, Sterile - TI-520-08-270-S9910643638info@auxein.com
08903993303863AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One 1.6mm Suture Tape: White - AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One 1.6mm Suture Tape: White/Blue9910643638info@auxein.com
089039933661102.7/3.5mm AV-Wiselock Medial Distal Humerus Plate, 1 Hole - Left, Stainless Stee - 2.7/3.5mm AV-Wiselock Medial Distal Humerus Plate, 1 Hole - Left, Stainless Steel9910643638info@auxein.com
08903993457009AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One #2 BioBraid: White/Blue - 6-001-019910643638info@auxein.com
08903993457368AUXILOCK® 2.8mm Titanium Screw-In Suture Anchor With One #2 BioBraid: White/Blue - 6-005-019910643638info@auxein.com
089039935951832.4mm Wise-Lock “T” Distal Radius Dorsal Plate (3 Head Holes),3 Holes,Titanium, - 2.4mm Wise-Lock “T” Distal Radius Dorsal Plate (3 Head Holes),3 Holes,Titanium, Sterile9910643638info@auxein.com
089039935951902.4mm Wise-Lock “T” Distal Radius Dorsal Plate (3 Head Holes),4 Holes, Titanium, - 2.4mm Wise-Lock “T” Distal Radius Dorsal Plate (3 Head Holes),4 Holes, Titanium, Sterile9910643638info@auxein.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1714661600219951K240181Clavicle and Scapula SystemHRS2024-10-09
1714661027164833K221787Auxein's DHS/DCS Plate SystemKTT2023-11-30
1714661441840223K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorMBI2022-12-16
1714661145991737K213109Auxilock Draw Tight Suture-Based AnchorMBI2022-08-22
1714661519953514K213108Humerus & Ulna SystemHRS2022-11-04
1714661174484834K213104Auxilock Titanium Screw-In Suture AnchorMBI2022-07-29
1714661047428444K213059Tibia and Fibula SystemHRS2023-01-27
1714661912918861K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateMBI2022-11-18
1714661443227048K213014Varixis Elbow SystemHRS2022-10-03
1714661006910780K2113242.4mm Distal Radius SystemHRS2022-03-14
1714661840110195K210792Auxein Nailing SystemHWC2021-08-25
1714661746713935K203029Auxilock Titanium Interference ScrewHWC2021-08-20
1714661889070061K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemNKB2021-04-06
1714661426958751K192003Auxein Nailing SystemJDS2020-06-10
1714661683667720K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking ScrewsHRS2015-06-30
1714661041330045
1714661072048647
1714661116757012
1714661124820762
1714661139863622
1714661149809256
1714661174913632
1714661194092419
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1714661203403383
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1714661459511927
1714661459524021
1714661471400789
1714661493048639
1714661505578946
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1714661518866601
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1714661528177431
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1714661607773285
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1714661662088164
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1714661684432045
1714661696470973
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1714661719634261
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1714661737212060
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1714661848590522
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1714661891069614
1714661910398737
1714661932333360
1714661932702858
1714661947429897
1714661947991382
1714661963950500
1714661970954097
1714661979616675
1714661985784496
1714662021773339
1714662027001252
1714662027417293
1714662028257357
1714662050131327
1714662061413861

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS62024-10-09
MBI42022-12-16
HWC22021-08-25
KTT12023-11-30
NKB12021-04-06
JDS12020-06-10

PMN#

GUDID#

200 records. Showing 1-40. Next