FDA.reportPublic FDA data

NA

Primary DI
20886982200003
Brand
NA
Company
Synthes GmbH
Model
394.99
Catalog number
39499
Device description
PROTECTIVE CAPS FOR 4.0MM BARS & RODS
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
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2
MQNExternal Mandibular Fixator And/Or DistractorDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050378000
K122455000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050378000SYNTHES MANDIBLE EXTERNAL FIXATORSynthes (Usa)2005-03-15MQN
K122455000SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMSynthes2013-04-11KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886982200003PrimaryGS10
H679394990SecondaryHIBCC0
80886982200005Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088698220000320886982200003
8088698220000580886982200005

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system noninvasive component, single-useA noninvasive structural component of an external orthopaedic fixation system intended for bone/joint fracture stabilization in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use 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
10
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
10886982346872MAXFRAMESynthes GmbHKTT2025-01-29
10886982343710MAXFRAMESynthes GmbHKTT2024-01-04
10886982343727MAXFRAMESynthes GmbHKTT2024-01-04
10886982343734MAXFRAMESynthes GmbHKTT2024-01-04
00841132142325eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142905eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142950eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132143025eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00888118108685LEVEL ONE CMFKLS-Martin L.P.MQN2017-08-17
10886982260659MAXFRAMESynthes GmbHKTT2017-04-19
10886982260666MAXFRAMESynthes GmbHKTT2017-04-19
10886982260673MAXFRAMESynthes GmbHKTT2017-04-19
10886982260680MAXFRAMESynthes GmbHKTT2017-04-19
10886982260697MAXFRAMESynthes GmbHKTT2017-04-19
10886982260703MAXFRAMESynthes GmbHKTT2017-04-19
10886982260710MAXFRAMESynthes GmbHKTT2017-04-19
10886982260727MAXFRAMESynthes GmbHKTT2017-04-19
10886982260734MAXFRAMESynthes GmbHKTT2017-04-19
10886982260741MAXFRAMESynthes GmbHKTT2017-04-19
10886982260758MAXFRAMESynthes GmbHKTT2017-04-19
10886982260765MAXFRAMESynthes GmbHKTT2017-04-19
10886982260772MAXFRAMESynthes GmbHKTT2017-04-19
10886982260789MAXFRAMESynthes GmbHKTT2017-04-19
10886982260796MAXFRAMESynthes GmbHKTT2017-04-19
10886982260802MAXFRAMESynthes GmbHKTT2017-04-19
10886982260819MAXFRAMESynthes GmbHKTT2017-04-19
10886982260826MAXFRAMESynthes GmbHKTT2017-04-19
10886982260833MAXFRAMESynthes GmbHKTT2017-04-19
10886982260840MAXFRAMESynthes GmbHKTT2017-04-19