FDA.reportPublic FDA data

NA

Primary DI
10886982200884
Brand
NA
Company
Synthes GmbH
Model
395.902
Catalog number
395902
Device description
1.25MM/1.6MM PROTECTION SLEEVE
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEYPLATE, BONE
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961350000
K971987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961350000SYNTHES MINI EXTERNAL FIXATORSynthes (Usa)1996-06-28KTT
K971987000SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATORSynthes (Usa)1997-06-24JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982200884PrimaryGS10
H6793959020SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698220088410886982200884

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. 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
10886982362179NASD03.043.006SD030430062026-07-24
10887587078557NASD03.503.067SD035030672026-07-24
10887587078564NASD03.503.072SD035030722026-07-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327616859HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616880HOFFMANN LRFStryker GmbHKTT2026-07-23
00888118154620LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
00888118154637LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
07613327616835HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327616866HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327694482DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
07613327694499DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
04046826346812MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826416676MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826542337MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826543655MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826552473MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
00888118126528LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2020-04-22
00841132142325eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142905eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142950eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132143025eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00888118006530LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118034717LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118034731LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118034748LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118034915LEVEL ONE NEUROKLS-Martin L.P.JEY2016-03-24
00888118035028LEVEL ONE NEUROKLS-Martin L.P.JEY2016-03-24
00888118035042LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118035721LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118035752LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118035882LEVEL ONE NEUROKLS-Martin L.P.JEY2016-03-24
00888118035912LEVEL ONE NEUROKLS-Martin L.P.JEY2016-03-24