FDA.reportPublic FDA data

Titanium Elastic Nail

Primary DI
08903993168684
Brand
Titanium Elastic Nail
Company
Auxein Medical Private Limited
Model
412-3.5-044
Device description
Titanium Elastic Nail, Ø3.5mm x Length 440mm
Published
2021-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDSNail, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDSNail, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192003000Auxein Nailing SystemAuxein Medical Private Limited2020-06-10JDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08903993168684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08903993168684089039931686848903993168684

GMDN Terms#

Term, Definition table
TermDefinition
Flexible bone nail, non-sterileA non-sterile, bending rod made of metal designed for insertion into the intramedullary canal of a long bone for fracture fixation where flexibility of the implant is desired. It is available in various lengths and diameters for use on lower and upper extremity diaphyseal fractures, and some metaphyseal fractures of paediatrics and small-statured/normal adults, to provide temporary stabilization of the bone segments/fragments until bone consolidation has been achieved. It is intended to splint the cortices and maintain elastic energy to continually brace against rotational/angular forces of the muscles. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+91 9910643638info@auxein.com

Regulatory Flags#

DUNS number
872194615
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08903993114377Expert Tibia Nail, Ø8mm x Length 255mm, Titanium, SterileTI-520-08-255-S2026-05-01
08903993114384Expert Tibia Nail, Ø8mm x Length 270mm, Titanium, SterileTI-520-08-270-S2026-05-01
089039935951832.4mm Wise-Lock “T” Distal Radius Dorsal Plate (3 Head Holes),3 Holes,Titanium, TI-M08.03-S2026-05-01
089039935951902.4mm Wise-Lock “T” Distal Radius Dorsal Plate (3 Head Holes),4 Holes, Titanium,TI-M08.04-S2026-05-01
08903993303863AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One 1.6mm Suture Tape: White6-001-082026-04-30
089039933661102.7/3.5mm AV-Wiselock Medial Distal Humerus Plate, 1 Hole - Left, Stainless Stee11-008-01SSL2026-04-30
08903993457009AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One #2 BioBraid: White/Blue6-001-012026-04-30
08903993457368AUXILOCK® 2.8mm Titanium Screw-In Suture Anchor With One #2 BioBraid: White/Blue6-005-012026-04-30
08903993457375AUXILOCK® 3.5mm Titanium Screw-In Suture Anchor With Two #2 BioBraid: White/Blue6-005-022026-04-30
08903993457467AUXILOCK® GFS Mini, Loop: 15mm, Button L: 12mm, W: 3.9mm6-007-022026-04-30
089039934959402.7/3.5mm AV-Wiselock Medial Distal Humerus Plate, 2 Holes - Left, Stainless Ste11-008-02SSL2026-04-30
089039936192922.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate, 3 Holes - Left, Stainless742.103L2026-04-30
089039936193082.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate, 3 Holes - Right, Stainles742.103R2026-04-30
08903993241486130° Wise-Lock DHS Plate, 2 Holes, Stainless Steel756.3002WL2026-04-18
08903993241493130° Wise-Lock DHS Plate, 3 Holes, Stainless Steel756.3003WL2026-04-18
089039933661342.7/3.5mm AV-Wiselock Medial Distal Tibia Plate, 4 Holes - Left, Stainless Steel11-019-04LSS2026-04-18
08903993457450AUXILOCK® GFS Mini, Loop: 12mm, Button L: 12mm, W: 3.9mm6-007-012026-04-18
089039934921093.5mm Wise-LocK Scapula Medial Border Plate, 9 Holes - Left, Titanium10-058-09LTI2026-04-18
089039934921163.5mm Wise-LocK Scapula Medial Border Plate, 13 Holes - Left, Titanium10-058-13LTI2026-04-18
089039934928022.7/3.5mm AV-Wiselock Medial Distal Tibia Plate, 6 Holes - Left, Stainless Steel11-019-06LSS2026-04-18

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Primary DI, Brand, Company table
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