FDA.reportPublic FDA data

NA

Primary DI
H6794749210
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
474.921
Catalog number
474921
Device description
15MM TI END CAP 10MM EXT
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
false
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
10886982234407PrimaryGS10
H6794749210SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698223440710886982234407

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail end-cap, sterileA small, sterile, 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
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
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
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