FDA.reportPublic FDA data

NA

Primary DI
10887587056111
Brand
NA
Company
Synthes GmbH
Model
488.075
Catalog number
488075
Device description
TI ALVEOLAR DISTRACTOR WITH STRAIGHT PLATE 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
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043555000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043555000SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTORSynthes (Usa)2005-04-12MQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587056111PrimaryGS10
H9804880750SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758705611110887587056111

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
00810112592986TriLEAP04.901.022049010222024-02-22
00810112592993TriLEAP04.901.024049010242024-02-22
00810112593006TriLEAP04.901.026049010262024-02-22
00810112593013TriLEAP04.901.028049010282024-02-22
00810112593020TriLEAP04.901.030049010302024-02-22
00810112593037TriLEAP04.902.008049020082024-02-22
00810112593044TriLEAP04.902.009049020092024-02-22
00810112593051TriLEAP04.902.010049020102024-02-22
00810112593068TriLEAP04.902.011049020112024-02-22
00810112593075TriLEAP04.902.012049020122024-02-22
00810112593082TriLEAP04.902.013049020132024-02-22
00810112593099TriLEAP04.902.014049020142024-02-22
00810112593105TriLEAP04.902.015049020152024-02-22
00810112593112TriLEAP04.902.016049020162024-02-22
00810112593129TriLEAP04.902.018049020182024-02-22
00810112593136TriLEAP04.902.020049020202024-02-22
00810112593143TriLEAP04.902.022049020222024-02-22
00810112593150TriLEAP04.902.024049020242024-02-22
00810112593167TriLEAP04.902.026049020262024-02-22
00810112593174TriLEAP04.902.028049020282024-02-22

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
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
00888118128676LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128683LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118112682LEVEL ONE CMFKLS-Martin L.P.MQN2018-01-26
00888118113399DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113405DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113412DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113429DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113436DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113443DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118108685LEVEL ONE CMFKLS-Martin L.P.MQN2017-08-17
00888118107800LEVEL ONE CMFKLS-Martin L.P.MQN2017-03-31
00888118107817LEVEL ONE CMFKLS-Martin L.P.MQN2017-03-31
00888118104007DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104014DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104021DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104038DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104045DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104052DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118105431DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118105554DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16