FDA.reportPublic FDA data

SynFix

Primary DI
10705034818337
Brand
SynFix
Company
Synthes GmbH
Model
SD03.835.034
Catalog number
SD03835034
Device description
SYNFIX EVOLUTION U-JOINT AWL ASSEMBLY
Published
2017-12-18
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
HWJAWL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034818337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503481833710705034818337

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982312327NA68.134.011681340112026-10-16
10886982346704VOLT68.134.111681341112026-10-16
10886982346735VOLT68.134.200681342002026-10-16
10886982363282NA68.045.017680450172026-10-16
10886982363299NA68.045.018680450182026-10-16
10886982363305NA68.045.019680450192026-10-16
10886982363312NA68.045.020680450202026-10-16
10705034753690ChronOS07.801.100.99S0780110099S2015-09-14
10705034753706ChronOS07.801.101.99S0780110199S2015-09-14
10705034753713ChronOS07.801.110.99S0780111099S2015-09-14
10705034753720ChronOS07.801.111.99S0780111199S2015-09-14
10705034753737ChronOS07.801.200.99S0780120099S2015-09-14
10705034799933ChronOS710.002.99S71000299S2015-09-14
10705034799940ChronOS710.014.99S71001499S2015-09-14
10705034799957ChronOS710.019.99S71001999S2015-09-14
10705034799964ChronOS710.021.99S71002199S2015-09-14
10705034799971ChronOS710.025.99S71002599S2015-09-14
10705034799988ChronOS710.026.99S71002699S2015-09-14
10705034799995ChronOS710.027.99S71002799S2015-09-14
10705034800004ChronOS710.038.99S71003899S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434786MillenniumAvalign Technologies, Inc.HWJ2026-10-12
00643169524699Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-09-20
04054896000770AwlSilony Medical GmbHHWJ2026-09-18
04054896000787AwlSilony Medical GmbHHWJ2026-09-18
04054896002927AwlSilony Medical GmbHHWJ2026-09-18
04054896005553AwlSilony Medical GmbHHWJ2026-09-18
04054896005560AwlSilony Medical GmbHHWJ2026-09-18
04054896005577AwlSilony Medical GmbHHWJ2026-09-18
04054896014999AwlSilony Medical GmbHHWJ2026-09-18
04054896015002AwlSilony Medical GmbHHWJ2026-09-18
04054896021669AwlSilony Medical GmbHHWJ2026-09-18
04054896024288AwlSilony Medical GmbHHWJ2026-09-18
04054896024295AwlSilony Medical GmbHHWJ2026-09-18
04054896024301AwlSilony Medical GmbHHWJ2026-09-18
04054896024318AwlSilony Medical GmbHHWJ2026-09-18
04054896032818AwlSilony Medical GmbHHWJ2026-09-18
04054896052595AwlSilony Medical GmbHHWJ2026-09-18
04054896052601AwlSilony Medical GmbHHWJ2026-09-18
04054896056777AwlSilony Medical GmbHHWJ2026-09-18
04054896069289AwlSilony Medical GmbHHWJ2026-09-18
04054896079325AwlSilony Medical GmbHHWJ2026-09-18
04054896079332AwlSilony Medical GmbHHWJ2026-09-18
04054896079349AwlSilony Medical GmbHHWJ2026-09-18
04054896079356AwlSilony Medical GmbHHWJ2026-09-18
04054896079363AwlSilony Medical GmbHHWJ2026-09-18
04054896079370AwlSilony Medical GmbHHWJ2026-09-18
04054896079387AwlSilony Medical GmbHHWJ2026-09-18
04054896079394AwlSilony Medical GmbHHWJ2026-09-18
04054896079578AwlSilony Medical GmbHHWJ2026-09-18
04054896079585AwlSilony Medical GmbHHWJ2026-09-18