FDA.reportPublic FDA data

NA

Primary DI
H6792028200
Brand
NA
Company
Synthes GmbH
Model
202.820
Catalog number
202820
Device description
2.7MM CORTEX SCREW SELF-TAPPING 20MM
Published
2015-09-14
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTWAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single ComponentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982144768PrimaryGS10
H6792028200SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698214476810886982144768

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must 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
DM exempt
false
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
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
10886982218735NASYNTHES (U.S.A.) LPKTW2018-07-18
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08809265150213Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150220Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150237Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150244Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150251Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150268Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150275Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150282Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150299Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150305Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150312Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150329Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150336Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150510Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150527Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150534Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150541Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150572Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150589Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150596Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150602Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150671Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150688Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151203Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151210Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151227Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151234Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151241Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24