Optimotion Blue CR HCCR Total Knee System

GUDID B6961014512050

Tibial Stem Trial, 12mm x 75mm

OPTIMOTION IMPLANTS LLC

Joint prosthesis implantation kit, reusable
Primary Device IDB6961014512050
NIH Device Record Key05dea4d0-72a1-41c1-ac7e-37245ce6c426
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptimotion Blue CR HCCR Total Knee System
Version Model Number1014-5-1205
Company DUNS056559377
Company NameOPTIMOTION IMPLANTS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-678-6686
Emailsupport@optimotionimplants.com
Phone877-678-6686
Emailsupport@optimotionimplants.com
Phone877-678-6686
Emailsupport@optimotionimplants.com
Phone877-678-6686
Emailsupport@optimotionimplants.com
Phone877-678-6686
Emailsupport@optimotionimplants.com
Phone877-678-6686
Emailsupport@optimotionimplants.com
Phone877-678-6686
Emailsupport@optimotionimplants.com
Phone877-678-6686
Emailsupport@optimotionimplants.com
Phone877-678-6686
Emailsupport@optimotionimplants.com
Phone877-678-6686
Emailsupport@optimotionimplants.com
Phone877-678-6686
Emailsupport@optimotionimplants.com
Phone877-678-6686
Emailsupport@optimotionimplants.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB6961014512050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B6961014512050]

Moist Heat or Steam Sterilization

[B6961014512050]

Moist Heat or Steam Sterilization

[B6961014512050]

Moist Heat or Steam Sterilization

[B6961014512050]

Moist Heat or Steam Sterilization

[B6961014512050]

Moist Heat or Steam Sterilization

[B6961014512050]

Moist Heat or Steam Sterilization

[B6961014512050]

Moist Heat or Steam Sterilization

[B6961014512050]

Moist Heat or Steam Sterilization

[B6961014512050]

Moist Heat or Steam Sterilization

[B6961014512050]

Moist Heat or Steam Sterilization

[B6961014512050]

Moist Heat or Steam Sterilization

[B6961014512050]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-04
Device Publish Date2020-07-27

On-Brand Devices [Optimotion Blue CR HCCR Total Knee System]

B6961014S22500Tibial Tray Stem, 22mm x 150mm
B6961014S22150Tibial Tray Stem, 22mm x 115mm
B6961014S22050Tibial Tray Stem, 22mm x 75mm
B6961014S20500Tibial Tray Stem, 20mm x 150mm
B6961014S20150Tibial Tray Stem, 20mm x 115mm
B6961014S20050Tibial Tray Stem, 20mm x 75mm
B6961014S18500Tibial Tray Stem, 18mm x 150mm
B6961014S18150Tibial Tray Stem, 18mm x 115mm
B6961014S18050Tibial Tray Stem, 18mm x 75mm
B6961014S16500Tibial Tray Stem, 16mm x 150mm
B6961014S16150Tibial Tray Stem, 16mm x 115mm
B6961014S16050Tibial Tray Stem, 16mm x 75mm
B6961014S14500Tibial Tray Stem, 14mm x 150mm
B6961014S14150Tibial Tray Stem, 14mm x 115mm
B6961014S14050Tibial Tray Stem, 14mm x 75mm
B6961014S12500Tibial Tray Stem, 12mm x 150mm
B6961014S12150Tibial Tray Stem, 12mm x 115mm
B6961014S12050Tibial Tray Stem, 12mm x 75mm
B6961014S10500Tibial Tray Stem, 10mm x 150mm
B6961014S10150Tibial Tray Stem, 10mm x 115mm
B6961014S10050Tibial Tray Stem, 10mm x 75mm
B6961014P39110Patella, UHMWPE with Vitamin E, 39mm x 11mm
B6961014P36100Patella, UHMWPE with Vitamin E, 36mm x 10mm
B6961014P33090Patella, UHMWPE with Vitamin E, 33mm x 9mm
B6961014P31090Patella, UHMWPE with Vitamin E, 31mm x 9mm
B6961014P29080Patella, UHMWPE with Vitamin E, 29mm x 8mm
B6961014P27080Patella, UHMWPE with Vitamin E, 27mm x 8mm
B6961014P18190Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 8, Thickness 19mm
B6961014P18170Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 8, Thickness 17mm
B6961014P18150Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 8, Thickness 15mm
B6961014P18130Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 8, Thickness 13mm
B6961014P18110Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 8, Thickness 11mm
B6961014P18090Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 8, Thickness 9mm
B6961014P17190Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 7, Thickness 19mm
B6961014P17170Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 7, Thickness 17mm
B6961014P17150Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 7, Thickness 15mm
B6961014P17130Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 7, Thickness 13mm
B6961014P17110Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 7, Thickness 11mm
B6961014P17090Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 7, Thickness 9mm
B6961014P16190Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 6, Thickness 19mm
B6961014P16170Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 6, Thickness 17mm
B6961014P16150Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 6, Thickness 15mm
B6961014P16130Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 6, Thickness 13mm
B6961014P16110Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 6, Thickness 11mm
B6961014P16090Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 6, Thickness 9mm
B6961014P15190Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 5, Thickness 19mm
B6961014P15170Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 5, Thickness 17mm
B6961014P15150Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 5, Thickness 15mm
B6961014P15130Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 5, Thickness 13mm
B6961014P15110Highly Congruent CR Tibial Insert, UHMWPE + Vitamin E, Size 5, Thickness 11mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.