FDA.reportPublic FDA data

NA

Primary DI
10886982347466
Brand
NA
Company
Synthes GmbH
Model
SD03.010.530
Catalog number
SD03010530
Device description
RIGID INSERTION SLEEVE
Published
2024-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDSNAIL, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDSNail, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111667000SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTSSynthes (Usa)2011-12-05JDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982347466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698234746610886982347466

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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
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
00885556165560NASmith & Nephew, Inc.JDS2026-07-16
00193982660086AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
00193982660109AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
00193982660123AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
00193982660147AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
00193982660161AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
00193982660185AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
00193982660208AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
00193982660222AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
00193982660246AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
00193982660260AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
00193982660284AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
00193982660307AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
00193982660321AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-06-10
08905892004599GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004605GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004612GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004629GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004636GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004643GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004650GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004667GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004674GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004681GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004698GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004704GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004711GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004728GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004735GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004742GPCGPC MEDICAL LIMITEDJDS2024-01-31