Rotaglide+ Modular Knee System with Fixed Meniscus 217.637

GUDID 05055343809648

Small patella peg drill guide

CORIN LTD

Orthopaedic implant aiming/guiding block, reusable
Primary Device ID05055343809648
NIH Device Record Keydf326a79-b36a-483e-8c6f-c4c2e10b3528
Commercial Distribution StatusIn Commercial Distribution
Brand NameRotaglide+ Modular Knee System with Fixed Meniscus
Version Model Number217.637
Catalog Number217.637
Company DUNS295437313
Company NameCORIN LTD
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

Phone+441285659866
Emailrachel.king@coringroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055343809648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05055343809648]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-17

On-Brand Devices [Rotaglide+ Modular Knee System with Fixed Meniscus]

05055343893623X-ray template: 115% stem extensions
05055343893616X-ray template: 115% tibiae: a-p view
05055343893609X-ray template: 115% tibiae: m-l view
05055343893593X-ray template: 115% pegged femur: XL
05055343893586X-ray template: 115% pegged femur: L
05055343893579X-ray template: 115% pegged femur: M
05055343893562X-ray template: 115% pegged femur: S
05055343893555X-ray template: 115% pegged femur: XS
05055343866160Patella drill
05055343866153Femur/ tibia peg drill
05055343809662Large patella peg drill guide
05055343809655Medium patella peg drill guide
05055343809648Small patella peg drill guide
05055343808856Patella presurisation clamp
05055343804346Alignment guide rod
05055196975293TIBIA BASEPLATE WITH LATCH
05055196975279TIBIA BASEPLATE WITH LATCH
05055196975262TIBIA BASEPLATE WITH LATCH
05055196975248TIBIA BASEPLATE WITH LATCH
05055196975231TIBIA BASEPLATE WITH LATCH
05055196975217TIBIA BASEPLATE WITH LATCH
05055196975200TIBIA BASEPLATE WITH LATCH
05055196975187TIBIA BASEPLATE WITH LATCH
05055196975170TIBIA BASEPLATE WITH LATCH
05055196975156TIBIA BASEPLATE WITH LATCH
05055196968172Tibial stylus
05055196967335IM tibial resection jig
05055196966895Distal resection block support arm
05055196966604Spacer handle
0505519696659817 mm RTK+ spacer
0505519696658114.5 mm RTK+ spacer
0505519696657412 mm RTK+ spacer
050551969665679.5 mm RTK+ spacer
050551969665507 mm RTK+ spacer
050551969664069º Bushing guide
050551969663907º Bushing guide
050551969663835º Bushing guide
050551969663763º Bushing guide
05055196966345Femoral introducer handle
05055196966314IM rod
05055196965850Tibial EM alignment guide
05055196965706Tibial trial 17.0 mm mobile
05055196965690Tibial trial 14.5 mm mobile
05055196965683Tibial trial 12.0 mm mobile
05055196965676Tibial trial 9.5 mm mobile
05055196965669Tibial trial 7.0 mm mobile
05055196965584Fixed bearing impactor
05055196960459Posterior reference guide
05055196954649Contents of pin box, consisting of:-
05055196954571Angel wing

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