FDA.reportPublic FDA data

EXPERT TIBIA NAIL

Primary DI
08903993392645
Brand
EXPERT TIBIA NAIL
Company
Auxein Medical Private Limited
Model
TI-520-058-62
Device description
Ø4.4mm Locking Bolt, Self Tapping, Length 62mm, Titanium
Published
2020-10-21
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
HBSInstrument, Clip Forming/Cutting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBSInstrument, Clip Forming/CuttingNeurology1

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
08903993392645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08903993392645089039933926458903993392645

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+919910643638info@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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849233010437BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
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00849233010635Busse Hospital DisposablesROBERT BUSSE & CO., INC.HBS2023-12-15
30849233010438BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
10849233010441BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
10849233010632Busse Hospital DisposablesROBERT BUSSE & CO., INC.HBS2023-12-15
07899893233069NEONAILNeoortho Produtos Ortopédicos S/A.HBS2023-10-31
07899893262038NEONAILNeoortho Produtos Ortopédicos S/A.HBS2023-10-27
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07540194008763SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008770SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
04048266166623OsteoBridge™ IDSF Diaphysis Tibial NailMerete GmbHHBS2018-10-31