FDA.reportPublic FDA data

NA

Primary DI
10886982296092
Brand
NA
Company
Synthes GmbH
Model
04.045.805S
Catalog number
04045805S
Device description
END CAP FOR FRNA / 5MM STERILE
Published
2021-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
K172157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172157000DePuy Synthes Femoral Recon Nail SystemSynthes (USA) Products, LLC2017-11-14HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982296092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698229609210886982296092

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail end-capA small, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982239297NA519.51519512017-02-20
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00193982471477AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471491AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471514AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471538AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471767AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471781AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471804AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471828AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471842AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471866AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471880AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472115AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472139AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472153AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472177AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472191AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472214AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472238AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473822AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473846AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473860AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473884AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473907AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473921AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473945AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982474171AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982474195AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14