FDA.reportPublic FDA data

NA

Primary DI
20886982180848
Brand
NA
Company
Synthes GmbH
Model
292.708
Catalog number
292708
Device description
1.6MM KIRSCHNER WIRE W/ THREADED TIP 100MM
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
JEYPLATE, BONE
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961350000
K971987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961350000SYNTHES MINI EXTERNAL FIXATORSynthes (Usa)1996-06-28KTT
K971987000SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATORSynthes (Usa)1997-06-24JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886982180848PrimaryGS10
H6792927080SecondaryHIBCC0
80886982180840Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088698218084820886982180848
8088698218084080886982180840

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. 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
10
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14
10886982077899NA03.311.013033110132015-09-14
10886982078131NA03.311.058033110582015-09-14
10886982078148NA03.311.059033110592015-09-14
10886982078155NA03.311.060033110602015-09-14
10886982078186NA03.311.062033110622015-09-14
10886982078193NA03.311.070033110702015-09-14
10886982078209NA03.311.071033110712015-09-14
10886982078247NA03.311.090033110902015-09-14
10886982078254NA03.311.091033110912015-09-14
10886982078261NA03.311.092033110922015-09-14
10886982078438NA03.311.201033112012015-09-14
10886982078445NA03.311.202033112022015-09-14
10886982078452NA03.311.203033112032015-09-14
10886982078469NA03.311.204033112042015-09-14
10886982078476NA03.311.205033112052015-09-14
10886982078520NA03.311.220033112202015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046826346812MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826416676MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826542337MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826543655MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826552473MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
00888118126528LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2020-04-22
10886982260659MAXFRAMESynthes GmbHKTT2017-04-19
10886982260666MAXFRAMESynthes GmbHKTT2017-04-19
10886982260673MAXFRAMESynthes GmbHKTT2017-04-19
10886982260680MAXFRAMESynthes GmbHKTT2017-04-19
10886982260697MAXFRAMESynthes GmbHKTT2017-04-19
10886982260703MAXFRAMESynthes GmbHKTT2017-04-19
10886982260710MAXFRAMESynthes GmbHKTT2017-04-19
10886982260727MAXFRAMESynthes GmbHKTT2017-04-19
10886982260734MAXFRAMESynthes GmbHKTT2017-04-19
10886982260741MAXFRAMESynthes GmbHKTT2017-04-19
10886982260758MAXFRAMESynthes GmbHKTT2017-04-19
10886982260765MAXFRAMESynthes GmbHKTT2017-04-19
10886982260772MAXFRAMESynthes GmbHKTT2017-04-19
10886982260789MAXFRAMESynthes GmbHKTT2017-04-19
10886982260796MAXFRAMESynthes GmbHKTT2017-04-19
00888118006530LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118034717LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118034731LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118034748LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118034915LEVEL ONE NEUROKLS-Martin L.P.JEY2016-03-24
00888118035028LEVEL ONE NEUROKLS-Martin L.P.JEY2016-03-24
00888118035042LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118035721LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118035752LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24