FDA.reportPublic FDA data

SLK Evo

Primary DI
05051693400054
Brand
SLK Evo
Company
IMPLANTS INTERNATIONAL LTD
Model
CR Femoral (STD) Left 65mm
Catalog number
KS5964
Device description
Cruciate Retaining Femoral Componant for Cemented applications (Cobalt Chrome), Denoted size 65mm (Width) Anatomical Orientation - Left
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
05051693400054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051693400054050516934000545051693400054

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee femur prosthesis, metallicAn implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width65Millimeter

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
+4401642769080mohan.emmanuel@implantsinternational.com
+4401642769080enquiries@implantsinternational.com
+4401642769080michael.russon@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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08906067247520Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247537Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05