FDA.reportPublic FDA data

CONQUEST FN

Primary DI
00885556705162
Brand
CONQUEST FN
Company
Smith & Nephew, Inc.
Model
71179231
Catalog number
71179231
Device description
CONQUEST FN PROXIMAL SCREW TAP
Published
2018-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDODEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDODevice, Fixation, Proximal Femoral, ImplantOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152686000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152686000CONQUEST FNSmith & Nephew2016-03-17JDO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556705162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556705162008855567051628855567051620885556705162

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010627308JOURNEY71422341714223412015-08-30
03596010627315JOURNEY71422342714223422015-08-30
03596010627339JOURNEY71422344714223442015-08-30
03596010627346JOURNEY71422345714223452015-08-30
03596010627360JOURNEY71422347714223472015-08-30
03596010627377JOURNEY71422351714223512015-08-30
03596010627384JOURNEY71422352714223522015-08-30
03596010627391JOURNEY71422353714223532015-08-30
03596010627407JOURNEY71422354714223542015-08-30
03596010627421JOURNEY71422356714223562015-08-30
03596010627438JOURNEY71422357714223572015-08-30
03596010629777JOURNEY71422346714223462015-08-30
03596010627322JOURNEY71422343714223432015-08-30
03596010627414JOURNEY71422355714223552015-08-30
03596010627445JOURNEY71422361714223612015-08-30
03596010627452JOURNEY71422362714223622015-08-30
03596010627469JOURNEY71422363714223632015-08-30
03596010627476JOURNEY71422364714223642015-08-30
03596010627483JOURNEY71422365714223652015-08-30
03596010627490JOURNEY71422366714223662015-08-30

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08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11