APEX Knee System KC-1155R

GUDID 00841690129523

CR Femoral Cemented, Size 5+ Right

Omnilife Science, Inc

Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic
Primary Device ID00841690129523
NIH Device Record Keybe82457a-9cab-48d7-8d42-bfeedc4bc4c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPEX Knee System
Version Model NumberKC-1155R
Catalog NumberKC-1155R
Company DUNS061339651
Company NameOmnilife Science, Inc
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841690129523 [Primary]

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841690129523]

Ethylene Oxide

[00841690129523]

Ethylene Oxide

[00841690129523]

Ethylene Oxide

[00841690129523]

Ethylene Oxide

[00841690129523]

Ethylene Oxide

[00841690129523]

Ethylene Oxide

[00841690129523]

Ethylene Oxide

[00841690129523]

Ethylene Oxide

[00841690129523]

Ethylene Oxide

[00841690129523]

Ethylene Oxide

[00841690129523]

Ethylene Oxide

[00841690129523]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-11
Device Publish Date2017-10-17

On-Brand Devices [APEX Knee System]

00841690130123Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 28mm
00841690130116Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 24mm
00841690130109Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 20mm
00841690130093Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 18mm
00841690130086Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 16mm
00841690130079Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 14mm
00841690130062Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 12mm
00841690130055Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 11mm
00841690130048Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 10mm
00841690130031Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 20mm
00841690130024Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 18mm
00841690130017Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 16mm
00841690130000Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 14mm
00841690129998Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 13mm
00841690129981Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 12mm
00841690129974Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 11mm
00841690129967Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 10mm
00841690129950Retaining Bolt, Congruent or Ultra Insert, Revision Tibia Baseplate
00841690129745Revision Tibial Baseplate Size 1
00841690129738Revision Tibial Baseplate Size 6
00841690129721Revision Tibial Baseplate Size 5
00841690129714Revision Tibial Baseplate Size 4
00841690129707Revision Tibial Baseplate Size 3
00841690129691Revision Tibial Baseplate Size 2
00841690129622PS femur, cemented Size 6+ Right
00841690129615PS femur, cemented Size 6+ Left
00841690129608PS femur, cemented Size 5+ Right
00841690129592PS femur, cemented Size 5+ Left
00841690129547CR Femoral Cemented, Size 6+ Right
00841690129530CR Femoral Cemented, Size 6+ Left
00841690129523CR Femoral Cemented, Size 5+ Right
00841690129516CR Femoral Cemented, Size 5+ Left
00841690128977Stem Retaining Bolt, Revision Femur
00841690128960Femoral Augment, Notched Posterior, Size 1, 10mm
00841690128953Femoral Augment, Notched Posterior, Size 5+, 10mm
00841690128946Femoral Augment, Notched Posterior, Size 4+, 10mm
00841690128939Femoral Augment, Notched Posterior, Size 3+, 10mm
00841690128922Femoral Augment, Notched Posterior, Size 2+, 10mm
00841690128915Femoral Augment, Notched Posterior, Size 1+, 10mm
00841690128908Revision Fluted Offset Stem 24mm x 150mm x 4mm
00841690128892Revision Fluted Offset Stem 24mm x 100mm x 4mm
00841690128885Revision Fluted Stem 24mm x 150mm
00841690128878Revision Fluted Stem 24mm x 100mm
00841690128861Revision Fluted Offset Stem 22mm x 150mm x 4mm
00841690128854Revision Fluted Offset Stem 22mm x 100mm x 4mm
00841690128847Revision Fluted Stem 22mm x 150mm
00841690128830Revision Fluted Stem 22mm x 100mm
00841690128823Revision Fluted Offset Stem 20mm x 150mm x 4mm
00841690128816Revision Fluted Offset Stem 20mm x 100mm x 4mm
00841690128809Revision Fluted Stem 20mm x 150mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.