FDA.reportPublic FDA data

NA

Primary DI
10886982203748
Brand
NA
Company
Synthes GmbH
Model
400.812.96
Catalog number
40081296
Device description
1.5MM TI CORTEX SCREW SELF-TAPPING 12MM
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
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980199000
K981275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980199000SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSSynthes (Usa)1998-04-17DZL
K981275000SYNTHES (USA) RATCHETING DISTRACTORSynthes (Usa)1998-06-25MQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982203748PrimaryGS10
H679400812960SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698220374810886982203748

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
1
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
00888118108685LEVEL ONE CMFKLS-Martin L.P.MQN2017-08-17
00888118006189LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118006202LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118006226LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118007261LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118007278LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118032812LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118037480LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118037503LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118037510LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118039439LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118039446LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044457LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044471LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044495LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044518LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044532LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044556LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044631LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044655LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044679LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045010LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045034LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045058LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045072LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045096LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045119LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045133LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045195LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045485LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24