FDA.reportPublic FDA data

NA

Primary DI
H6794749120
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
474.912
Catalog number
474912
Device description
120 DEG TI LOCKING SLEEVE F/ 13-15MM TI CANN FEMORAL NAILS
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
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
10886982234346PrimaryGS10
H6794749120SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698223434610886982234346

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

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