FDA.reportPublic FDA data

4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 10 Holes

Primary DI
08903993215548
Brand
4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 10 Holes
Company
Auxein Medical Private Limited
Model
725.210
Catalog number
A3-DND-QF-001-WF3
Device description
The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
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
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, 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
08903993215548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08903993215548089039932155488903993215548

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

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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