FDA.reportPublic FDA data

3.5mm Wise-Lock Screws, Self Tapping, Length 42 mm

Primary DI
08903993258378
Brand
3.5mm Wise-Lock Screws, Self Tapping, Length 42 mm
Company
Auxein Medical Private Limited
Model
117.042
Catalog number
A3-DND-QF-001-WF3
Device description
Screws are used to affix the plate to the bone
Published
2018-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141680000AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking ScrewsAuxein Medical2015-06-30HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08903993258378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08903993258378089039932583788903993258378

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate kit, non-bioabsorbable, sterileA sterile collection of small sheets of firm material and bone screws intended to be implanted onto fractured bone fragments to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Tools for implantation may be included. The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
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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