FDA.reportPublic FDA data

NA

Primary DI
10887587016450
Brand
NA
Company
Synthes GmbH
Model
04.500.000
Catalog number
04500000
Device description
TI MAXILLARY ROD-110MM F/EXTERNAL MIDFACE 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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040083000SYNTHES EXTERNAL MIDFACE DISTRACTORSynthes (Usa)2004-03-31MQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587016450PrimaryGS10
H980045000000SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758701645010887587016450

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, reusableAn assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. This is a reusable device.

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