FDA.reportPublic FDA data

NA

Primary DI
10886982231574
Brand
NA
Company
Synthes GmbH
Model
459.50
Catalog number
45950
Device description
4.9MM TI LOCKING BOLT 50MM
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HTYPIN, FIXATION, SMOOTH
JDNIMPLANT, FIXATION DEVICE, SPINAL
JDSNAIL, FIXATION, BONE
JDWPIN, FIXATION, THREADED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HTYPin, Fixation, SmoothOrthopedic2
JDNImplant, Fixation Device, SpinalOrthopedic2
JDSNail, Fixation, BoneOrthopedic2
JDWPin, Fixation, ThreadedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914371000
K923580000
K954856000
K962047000
K970097000
K970733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914371000UNIVERSAL FEMORAL NAILSynthes (Usa)1992-02-18JDS
K923580000SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAILSynthes (Usa)1993-01-21HSB
K954856000CANNULATED FEMORAL NAILSynthes (Usa)1996-03-08JDN
K962047000TITANIUM CANNULATED TIBIAL NAIL (TI CTN)Synthes (Usa)1996-07-24JDS
K970097000PROXIMAL FEMORAL NAIL (PFN) SYSTEMSynthes (Usa)1997-03-13JDW
K970733000SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEMSynthes (Usa)1997-04-02HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982231574PrimaryGS10
H679459500SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698223157410886982231574

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone boltA short, implantable rod or shaft designed to be inserted through a long bone (excludes spinal bone) to secure the bone for traction or for a similar process/apparatus. The device is fastened with a nut/washer, and is typically made of metal or a polymer. It is typically used in the proximal tibia or distal femur. 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
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14

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