FDA.reportPublic FDA data

NA

Primary DI
07613327504408
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
92-02323
Catalog number
92-02323
Device description
PEDIATRIC MANDIBULAR DISTRACTOR 2
Published
2020-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K181504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181504000Stryker Pediatric Mandibular Distractor 2Stryker2018-09-11MQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327504408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327504408076133275044087613327504408

GMDN Terms#

Term, Definition table
TermDefinition
Implantable craniofacial bone distractorAn 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 when gradual bone augmentation is required. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height5Millimeter
Length60Millimeter
Width15Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
37613327122962NA29-9300329-930032018-04-13
04546540274250NA64-0013264-001322017-01-11
07613327122893NA29-9300129-930012017-12-01
07613327122909NA29-9200129-920012017-03-31
07613327122916NA29-9200329-920032017-03-31
07613327122930NA29-9200229-920022017-03-31
07613327122947NA29-9100229-910022017-03-31
07613327122978NA29-9300229-930022017-12-01
07613327123326NA29-9200429-920042017-03-31
37613154881872PINABALL6003-003-0906003-003-0902016-09-21
57613252088436TLS, Quintube663066302016-08-24
07613327465532NA92-0023292-002322019-05-03
07613327465549NA92-0023092-002302019-05-03
04546540134790NA01-0323001-032302017-01-11
04546540134974NA01-0401001-040102016-12-08
04546540134998NA01-0407001-040702016-12-08
04546540135018NA01-0410001-041002016-12-08
04546540138477NA01-0956101-095612016-12-08
04546540141514NA01-1531501-153152017-01-11
04546540143242NA01-1971501-197152016-12-08

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