FDA.reportPublic FDA data

NA

Primary DI
10887587015484
Brand
NA
Company
Synthes GmbH
Model
04.315.028
Catalog number
04315028
Device description
BC DISTRACTOR BODY END ACT 40MM FOR CMF DISTRACTOR
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
PBJCranial Distraction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQNExternal Mandibular Fixator And/Or DistractorDental2
PBJCranial Distraction SystemNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060138000
K162594000
K170818000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060138000SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEMSynthes (Usa)2006-06-02MQN
K162594000Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC2017-05-08MQN
K170818000Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC2017-12-07PBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587015484PrimaryGS10
H980043150280SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758701548410887587015484

GMDN Terms#

Term, Definition table
TermDefinition
Implantable craniofacial bone distractorA non-powered implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.

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
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26
10886982064806NA03.000.076S03000076S2016-06-30

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