FDA.reportPublic FDA data

NA

Primary DI
10887587015682
Brand
NA
Company
Synthes GmbH
Model
04.315.132
Catalog number
04315132
Device description
REMOVABLE EXTENSION ARM-FLEX 60MM 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
K080153000
K162594000
K170818000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060138000SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEMSynthes (Usa)2006-06-02MQN
K080153000SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEMSynthes (Usa)2008-05-14MQN
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
10887587015682PrimaryGS10
H980043151320SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758701568210887587015682

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone distractor extensionA partially-implantable device intended to be temporarily used as an extension for an implanted or partially-implanted craniofacial distractor allowing connection to the central adjustment thread of the distractor when its location is made difficult to access due to its surgical positioning. It is used to allow the required rotation of the thread in order to distract (force apart) the two bone surfaces of the mandibular body (the lower jawbone) during the adjustment period. It is typically made of high-grade stainless steel and may be rigid or flexible in design.

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
10886982198266NA391.73391732016-12-31
10886982312259NA60.133.200601332002022-04-12
10886982312266NA60.133.300601333002022-06-17
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982199539NASynthes GmbHMQN2015-09-14
10886982199560NASynthes GmbHMQN2015-09-14
10886982200419NASynthes GmbHMQN2015-09-14
10886982200426NASynthes GmbHMQN2015-09-14
10886982200433NASynthes GmbHMQN2015-09-14
10886982203502NASynthes GmbHMQN2015-09-14
10886982203519NASynthes GmbHMQN2015-09-14
10886982203526NASynthes GmbHMQN2015-09-14
10886982203533NASynthes GmbHMQN2015-09-14
10886982203540NASynthes GmbHMQN2015-09-14
10886982203557NASynthes GmbHMQN2015-09-14
10886982203564NASynthes GmbHMQN2015-09-14
10886982203571NASynthes GmbHMQN2015-09-14
10886982203588NASynthes GmbHMQN2015-09-14
10886982203595NASynthes GmbHMQN2015-09-14
10886982203601NASynthes GmbHMQN2015-09-14
10886982203618NASynthes GmbHMQN2015-09-14
10886982203625NASynthes GmbHMQN2015-09-14
10886982203632NASynthes GmbHMQN2015-09-14
10886982203649NASynthes GmbHMQN2015-09-14
10886982203656NASynthes GmbHMQN2015-09-14
10886982203663NASynthes GmbHMQN2015-09-14
10886982203670NASynthes GmbHMQN2015-09-14
10886982203687NASynthes GmbHMQN2015-09-14
10886982203694NASynthes GmbHMQN2015-09-14
10886982203700NASynthes GmbHMQN2015-09-14
10886982203717NASynthes GmbHMQN2015-09-14
10886982203724NASynthes GmbHMQN2015-09-14
10886982203731NASynthes GmbHMQN2015-09-14
10886982203748NASynthes GmbHMQN2015-09-14