FDA.reportPublic FDA data

3.5mm x 42mm Cannulated Headed Screw

Primary DI
00814289020587
Brand
3.5mm x 42mm Cannulated Headed Screw
Company
CONVENTUS ORTHOPAEDICS, INC.
Model
CH3542
Published
2015-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
JDSNail, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814289020587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814289020587008142890205878142890205870814289020587

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
021231299
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814289020006Conventus Cage - DR, SmallDRS-S2015-09-18
00814289020013Conventus Cage - DR, LargeDRS-L2015-09-18
008142890200202.7mm x 8mm Cannulated Headed ScrewBH27082015-09-18
008142890200372.7mm x 10mm Cannulated Headed ScrewBH27102015-09-18
008142890200442.7mm x 12mm Cannulated Headed ScrewBH27122015-09-18
008142890200512.7mm x 14mm Cannulated Headed ScrewBH27142015-09-18
008142890200682.7mm x 16mm Cannulated Headed ScrewBH27162015-09-18
008142890200752.7mm x 18mm Cannulated Headed ScrewBH27182015-09-18
008142890200822.7mm x 20mm Cannulated Headed ScrewBH27202015-09-18
008142890200992.7mm x 22mm Cannulated Headed ScrewBH27222015-09-18
008142890201052.7mm x 24mm Cannulated Headed ScrewBH27242015-09-18
008142890201122.7mm x 26mm Cannulated Headed ScrewBH27262015-09-18
008142890201292.7mm x 28mm Cannulated Headed ScrewBH27282015-09-18
008142890201362.7mm x 30mm Cannulated Headed ScrewBH27302015-09-18
008142890201432.7mm x 32mm Cannulated Headed ScrewBH27322015-09-18
008142890201502.7mm x 34mm Cannulated Headed ScrewBH27342015-09-18
008142890201672.7mm x 36mm Cannulated Headed ScrewBH27362015-09-18
008142890201742.7mm x 38mm Cannulated Headed ScrewBH27382015-09-18
008142890201812.7mm x 40mm Cannulated Headed ScrewBH27402015-09-18
008142890201982.7mm x 42mm Cannulated Headed ScrewBH27422015-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556165560NASmith & Nephew, Inc.JDS2026-07-16
07630894822858APTUSMedartis AGHRS2026-07-16
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07630894822872APTUSMedartis AGHRS2026-07-16
07630894822889APTUSMedartis AGHRS2026-07-16
07630894822896APTUSMedartis AGHRS2026-07-16
07630894822902APTUSMedartis AGHRS2026-07-16
07630894822919APTUSMedartis AGHRS2026-07-16
07630894822926APTUSMedartis AGHRS2026-07-16
07630894822933APTUSMedartis AGHRS2026-07-16
07630894822940APTUSMedartis AGHRS2026-07-16
07630894822957APTUSMedartis AGHRS2026-07-16
07630894822964APTUSMedartis AGHRS2026-07-16
07630894822971APTUSMedartis AGHRS2026-07-16
07630894822988APTUSMedartis AGHRS2026-07-16
07630894822995APTUSMedartis AGHRS2026-07-16
07630894823008APTUSMedartis AGHRS2026-07-16
07630894823015APTUSMedartis AGHRS2026-07-16
07630894823022APTUSMedartis AGHRS2026-07-16
07630894823039APTUSMedartis AGHRS2026-07-16
07630894823053APTUSMedartis AGHRS2026-07-16
07630894823060APTUSMedartis AGHRS2026-07-16
07630894823084APTUSMedartis AGHRS2026-07-16
07630894823091APTUSMedartis AGHRS2026-07-16
07630894823114APTUSMedartis AGHRS2026-07-16
07630894823121APTUSMedartis AGHRS2026-07-16
07630894823145APTUSMedartis AGHRS2026-07-16
07630894823152APTUSMedartis AGHRS2026-07-16
07630894823176APTUSMedartis AGHRS2026-07-16
07630894823183APTUSMedartis AGHRS2026-07-16