FDA.reportPublic FDA data

NA

Primary DI
20886982180978
Brand
NA
Company
Synthes GmbH
Model
292.79
Catalog number
29279
Device description
2.0MM KIRSCHNER WIRE W/15MM THREAD-TROCAR POINT 150mm
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
DZLSCREW, FIXATION, INTRAOSSEOUS
JDWPIN, FIXATION, THREADED
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2
JDWPin, Fixation, ThreadedOrthopedic2
MQNExternal Mandibular Fixator And/Or DistractorDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050378000
K981362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050378000SYNTHES MANDIBLE EXTERNAL FIXATORSynthes (Usa)2005-03-15MQN
K981362000SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORSynthes (Usa)1998-06-29DZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886982180978PrimaryGS10
H679292790SecondaryHIBCC0
80886982180970Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088698218097820886982180978
8088698218097080886982180970

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
00810112599275TriLEAP04.900.251049002512025-03-20
00810112599169TriLEAP04.900.240049002402025-03-18
00810112599763TriLEAP03.900.407039004072025-03-18
00810112599176TriLEAP04.900.241049002412025-03-17
00810112599183TriLEAP04.900.242049002422025-03-17
00810112599190TriLEAP04.900.243049002432025-03-17
00810112599206TriLEAP04.900.244049002442025-03-17
00810112599213TriLEAP04.900.245049002452025-03-17
00810112599220TriLEAP04.900.246049002462025-03-17
00810112599237TriLEAP04.900.247049002472025-03-17
00810112599244TriLEAP04.900.248049002482025-03-17
00810112599251TriLEAP04.900.249049002492025-03-17
00810112599268TriLEAP04.900.250049002502025-03-17
00810112592467TriLeap Lower Etremity Anatomic Plating System60.900.307609003072024-02-23
00810112592528TriLeap Lower Extremity Anatomic Plating03.900.311039003112024-02-23
00810112592566TriLeap Lower Etremity Anatomic Plating System03.900.332039003322024-02-23
00810112597035TriLeap Lower Extremity Plating System04.900.057049000572024-02-21
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118154910LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118154927LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118154934LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118154965LEVEL ONE CMF, STERILEKLS-Martin L.P.MQN2026-10-21
10888118154979LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
10888118154986LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00817421023668X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023675X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023682X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023699X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023705X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023712X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023729X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023736X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023743X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023750X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023767X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023774X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023781X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023798X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00083208006159Tatum Surgical Bone Fixation ScrewSuncoast Dental, IncDZL2026-08-14
00083208006166Tatum Surgical Bone Fixation ScrewSuncoast Dental, IncDZL2026-08-14
18032568033229Surgical InstrumentsORTHOFIX SRLJDW2026-07-23
18032568033236Surgical InstrumentsORTHOFIX SRLJDW2026-07-23
18032568036008WRIST FIXATION SYSTEMSORTHOFIX SRLJDW2026-07-23
07613327618501HOFFMANN LRFStryker GmbHJDW2026-07-21
00888118128638LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128645LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128652LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128669LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24