FDA.reportPublic FDA data

FRA

Primary DI
10705034774183
Brand
FRA
Company
Synthes GmbH
Model
389.051
Catalog number
389051
Device description
SMALL STATURE FRA IMPLANT HOLDER-SLOT
Published
2016-12-31
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
HYAFORCEPS, WIRE HOLDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYAForceps, Wire HoldingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034774183PrimaryGS10
H9813890510SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503477418310705034774183

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). 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
Premarket exempt
true
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
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03760225714096In2BonesIN2BONESHYA2024-12-13
04250603748526LAZICPeter Lazic GmbHHYA2024-11-20
04250603749295LAZICPeter Lazic GmbHHYA2024-11-20
03700569626877Newclip InstrumentsNEWCLIP TECHNICSHYA2024-11-08
03700569626884Newclip InstrumentsNEWCLIP TECHNICSHYA2024-11-08
04049197473248RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHYA2024-09-20
04049197473255RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHYA2024-09-20
00840183516758BR Surgical, LLCBR Surgical, LLCHYA2024-06-03
00840180519301General InstrumentsALPHATEC SPINE, INC.HYA2023-09-22
07898506853717QuinelatoSchobell Industrial LtdaHYA2023-07-07
07898506848676QuinelatoSchobell Industrial LtdaHYA2023-07-05
07898506814312QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853601QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853618QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853625QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853649QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853724QuinelatoSchobell Industrial LtdaHYA2022-12-16
07899798203310SchobellSchobell Industrial LtdaHYA2022-11-28
00840180508336General InstrumentsALPHATEC SPINE, INC.HYA2022-10-13
00887482055410Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HYA2022-08-25
00850027837642StabilICEACUTUS MEDICAL, INC.HYA2022-04-01
00850027837659StabilICEACUTUS MEDICAL, INC.HYA2022-04-01
04250603736608LAZICPeter Lazic GmbHHYA2021-12-22
04250603739487LAZICPeter Lazic GmbHHYA2021-12-22
00850027837529StabilICEACUTUS MEDICAL, INC.HYA2021-10-28
04250603736103LAZICPeter Lazic GmbHHYA2021-07-02
04250603736110LAZICPeter Lazic GmbHHYA2021-07-02