NA

Primary DI
07613327504415
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
92-02322
Catalog number
92-02322
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
07613327504415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327504415076133275044157613327504415

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
04546540256805NA62-0053462-005342016-10-19
04546540356628NA62-0030262-003022016-12-08
04546540366788NA62-2052062-205202016-10-19
04546540391391NA62-0020862-002082016-12-08
07613154185443NA62-0044162-004412016-12-08
07613154731800NA92-1592392-159232017-01-11
07613154732685NA92-1592192-159212017-01-11
07613252313069DELTA70-9200970-920092015-09-24
07613252444220DELTA70-9200670-920062015-09-24
07613252444244DELTA70-9200370-920032015-09-24
07613252727002DELTA70-9204770-920472015-09-24
07613327090123NA62-2014962-201492016-10-19
07613327090192NA62-2013962-201392016-10-19
07613327123340Delta70-9205670-920562015-09-24
07613327123364Delta70-9205570-920552015-09-24
07613252286578FLUOROMAP6006-600-0006006-600-0002025-01-28
07613327542202N/A81-8007081-800702023-05-11
07613327542219N/A6003-700-3006003-700-3002023-05-11
07613327542363N/A6003-710-3006003-710-3002023-05-11
07613327542370N/A81-8007181-800712023-05-11

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