FDA.reportPublic FDA data

SLK Evo

Primary DI
05051693400436
Brand
SLK Evo
Company
IMPLANTS INTERNATIONAL LTD
Model
CS Modular (PS) Tibial insert 55mm x 13mm
Catalog number
KS5771
Device description
Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 55mm (Width), 13mm (Thick)
Published
2016-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980999000ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANTInstrument Makar, Inc.1998-11-06JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051693400436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051693400436050516934004365051693400436

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width55Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room temperature and Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401642769080michael.russon@implantsinterna
+4401642769080michael.russon@implantsinternational.com
+4401642769080enquiries@implantsinternational.com
+4401642769080mohan.emmanuel@implantsinternational.com

Regulatory Flags#

DUNS number
346627222
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051693300330PerformaCollared Hip Stem - Size 1 (139 x 9mm)HS12042016-07-31
05051693300347PerformaCollared Hip Stem - Size 2 (142 x 10mm)HS12052016-07-31
05051693300354PerformaCollared Hip Stem - Size 3 (146 x 11mm)HS12062016-07-31
05051693300361PerformaCollared Hip Stem - Size 4 (149 x 12mm)HS12072016-07-31
05051693300378PerformaCollared Hip Stem - Size 5 (153 x 13mm)HS12082016-07-31
05051693300385PerformaCollared Hip Stem - Size 6 (156 x 14mm)HS12092016-07-31
05051693300392PerformaCollared Hip Stem - Size 7 (160 x 15mm)HS12102016-07-31
05051693300408PerformaCollared Hip Stem - Size 8 (163 x 16mm)HS12112016-07-31
05051693300415PerformaCollared Hip Stem - Size 3-1 (165 x 11mm) LONGHS12902016-07-31
05051693300422PerformaCollared Hip Stem - Size 4 (165 x 12mm) LONGHS12912016-07-31
05051693300439PerformaCollared Hip Stem - Size 5 (165 x 13mm) LONGHS12922016-07-31
05051693300446PerformaCollared Hip Stem - Size 6 (165 x 14mm) LONGHS12932016-07-31
05051693300576StabilityFlanged Cemented Hip Stem - Size 1HS12202016-07-31
05051693300583StabilityFlanged Cemented Hip Stem - Size 2HS12212016-07-31
05051693300590StabilityFlanged Cemented Hip Stem - Size 3HS12222016-07-31
05051693300606StabilityFlanged Cemented Hip Stem - Size 4HS12232016-07-31
05051693300613StabilityFlanged Cemented Hip Stem - Size 5HS12242016-07-31
05051693300620StabilityFlanged Cemented Hip Stem - Size 6HS12252016-07-31
05051693300637StabilityStandard Cemented Hip Stem - Size 1HS12262016-07-31
05051693300644StabilityStandard Cemented Hip Stem - Size 2HS12272016-07-31

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Primary DI, Brand, Company table
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