FDA.reportPublic FDA data

NA

Primary DI
H679474336S0
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
474.336S
Catalog number
474336S
Device description
13MM TI CANNULATED FEMORAL NAIL 360MM-STERILE
Published
2015-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDNIMPLANT, FIXATION DEVICE, SPINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDNImplant, Fixation Device, SpinalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954856000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954856000CANNULATED FEMORAL NAILSynthes (Usa)1996-03-08JDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982233752PrimaryGS10
H679474336S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698223375210886982233752

GMDN Terms#

Term, Definition table
TermDefinition
Femur nailA rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use 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
832637081
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
true
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
10705034731650NA03.820.126038201262016-12-31
10705034731667NA03.820.127038201272016-12-31
10705034731674NA03.820.128038201282016-12-31
10705034731681NA03.820.129038201292016-12-31
10705034731759NA03.820.136038201362016-12-31
10705034731766NA03.820.137038201372016-12-31
10705034731896PRODISC L03.820.201038202012016-12-31
10705034731902PRODISC L03.820.202038202022016-12-31
10705034732008NA03.820.459038204592016-12-31
10705034732015NA03.820.462038204622016-12-31
10705034763729ProDisc-C09.820.025S09820025S2014-09-08
10705034763736ProDisc-C09.820.026S09820026S2014-09-08
10705034763750ProDisc-C09.820.035S09820035S2014-09-08
10705034763767ProDisc-C09.820.036S09820036S2014-09-08
10705034763781ProDisc-C09.820.045S09820045S2014-09-08
10705034763798ProDisc-C09.820.046S09820046S2014-09-08
10705034763804ProDisc-C09.820.047S09820047S2014-09-08
10705034763811ProDisc-C09.820.055S09820055S2014-09-08
10705034763828ProDisc-C09.820.056S09820056S2014-09-08
10705034763835ProDisc-C09.820.057S09820057S2014-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800038055322Mixing BowlIMEDICOM CO., LTD.JDN2023-08-08
00889024038042NAZimmer, Inc.JDN2015-09-24
00889024038097NAZimmer, Inc.JDN2015-09-24
10886982231338NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231352NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231376NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231390NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231413NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231437NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231451NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231475NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231499NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231512NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231536NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231550NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231574NASynthes GmbHJDN2015-09-14
10886982231598NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231611NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231635NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231659NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231673NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231697NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231710NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231734NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231758NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231772NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231796NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231819NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982231833NASYNTHES (U.S.A.) LPJDN2015-09-14
10886982233097NASYNTHES (U.S.A.) LPJDN2015-09-14