FDA.reportPublic FDA data

NA

Primary DI
10886982195739
Brand
NA
Company
Synthes GmbH
Model
357.052
Catalog number
357052
Device description
TROCHANTERIC FIXATION NAIL SCREW COMPRESSION NUT
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092646000SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREWSynthes (Usa)2009-09-25HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819073685Direct MarkingGS10
10886982195739PrimaryGS10
H6793570520SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819073685076118190736857611819073685
1088698219573910886982195739

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCHWC2026-07-17
07613327646825NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646832NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646849NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646856NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646863NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646870NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646887NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646894NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646900NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646917NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646931NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646948NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646955NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646962NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646979NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646986NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646993NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647006NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647013NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647020NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647037NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647044NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647051NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647069NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647076NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647090NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647106NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647113NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647120NAStryker Leibinger GmbH & Co. KGHWC2026-07-17