FDA.reportPublic FDA data

3.5mm x 42mm Locking Screw

Primary DI
00814289021140
Brand
3.5mm x 42mm Locking Screw
Company
CONVENTUS ORTHOPAEDICS, INC.
Model
SL3542
Published
2017-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JDSNail, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814289021140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814289021140008142890211408142890211400814289021140

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
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814289020754Conventus Cage - PR, SmallPR-S2015-12-31
00814289020761Conventus Cage - PR, LargePR-L2015-12-31
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

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