FDA.reportPublic FDA data

NA

Primary DI
20887587047352
Brand
NA
Company
Synthes GmbH
Model
401.532
Catalog number
401532
Device description
2.4MM TI CORTEX SCREW SELF-TAPPING 32MM
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
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2
MQNExternal Mandibular Fixator And/Or DistractorDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954385000
K961421000
K981275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954385000SYNTHES MANDIBULAR MODULAR FIXATION SYSTEMSynthes (Usa)1996-03-08JEY
K961421000SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEMSynthes (Usa)1996-06-26JEY
K981275000SYNTHES (USA) RATCHETING DISTRACTORSynthes (Usa)1998-06-25MQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20887587047352PrimaryGS10
H9804015320SecondaryHIBCC0
80887587047354Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088758704735220887587047352
8088758704735480887587047354

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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
5
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
05420060351235TRUMATCHMaterialise NVJEY2026-10-22
05420060351242TRUMATCHMaterialise NVJEY2026-10-22
05420060351259TRUMATCHMaterialise NVJEY2026-10-22
05420060351266TRUMATCHMaterialise NVJEY2026-10-22
05420060351273TRUMATCHMaterialise NVJEY2026-10-22
05420060351280TRUMATCHMaterialise NVJEY2026-10-22
05420060351297TRUMATCHMaterialise NVJEY2026-10-22
05420060351303TRUMATCHMaterialise NVJEY2026-10-22
05420060351310TRUMATCHMaterialise NVJEY2026-10-22
05420060351327TRUMATCHMaterialise NVJEY2026-10-22
05420060351334TRUMATCHMaterialise NVJEY2026-10-22
05420060351341TRUMATCHMaterialise NVJEY2026-10-22
05420060351358TRUMATCHMaterialise NVJEY2026-10-22
05420060351365TRUMATCHMaterialise NVJEY2026-10-22
05420060351372TRUMATCHMaterialise NVJEY2026-10-22
05420060351389TRUMATCHMaterialise NVJEY2026-10-22
05420060351396TRUMATCHMaterialise NVJEY2026-10-22
05420060351402TRUMATCHMaterialise NVJEY2026-10-22
00888118150288LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150295LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150301LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150318LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150325LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150332LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150349LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150356LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150363LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150370LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150387LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150394LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21