FDA.reportPublic FDA data

NA

Primary DI
H679040310260
Brand
NA
Company
Synthes GmbH
Model
04.031.026
Catalog number
04031026
Device description
5.0MM TI RECON SCREW W/T25 STARDRIVE 80MM
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
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070843000SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEMSynthes (Usa)2007-05-02HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982094025PrimaryGS10
H679040310260SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698209402510886982094025

GMDN Terms#

Term, Definition table
TermDefinition
Hip internal fixation systemAn assembly of implantable devices designed to treat fractures of the hip. It typically includes a metal plate that is held in position with fasteners such as screws and nails, or bolts, nuts and washers. The assembly is typically intended to treat stable or unstable intertrochanteric, pertrochanteric, and/or base of neck hip fractures.

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
10887587078540NASD03.501.442SD035014422026-07-29
10886982362179NASD03.043.006SD030430062026-07-24
10887587078557NASD03.503.067SD035030672026-07-24
10887587078564NASD03.503.072SD035030722026-07-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18059015376838Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376845Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376852Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376869Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376876Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376883Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376890Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376906Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376913Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376920Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376937Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376944Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376951Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376968Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376975Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376982Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376999Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377002Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377019Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377026Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377033Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377040Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377057Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377064Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377071Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377088Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377095Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377101Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377118Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377125Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23