Rotaglide+ Modular Knee System with Fixed Meniscus 102.013P

GUDID 05055196915145

RTK+ STEM FEMUR

CORIN LTD

Coated knee femur prosthesis

• Primary Device ID: 05055196915145
• NIH Device Record Key: dedf6b0d-a91f-496f-b85e-553ab65d4255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotaglide+ Modular Knee System with Fixed Meniscus
• Version Model Number: 102.013P
• Catalog Number: 102.013P
• Company DUNS: 295437313
• Company Name: CORIN LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196915145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000232

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[05055196915145]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

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

• 05055343893623: X-ray template: 115% stem extensions
• 05055343893616: X-ray template: 115% tibiae: a-p view
• 05055343893609: X-ray template: 115% tibiae: m-l view
• 05055343893593: X-ray template: 115% pegged femur: XL
• 05055343893586: X-ray template: 115% pegged femur: L
• 05055343893579: X-ray template: 115% pegged femur: M
• 05055343893562: X-ray template: 115% pegged femur: S
• 05055343893555: X-ray template: 115% pegged femur: XS
• 05055343866160: Patella drill
• 05055343866153: Femur/ tibia peg drill
• 05055343809662: Large patella peg drill guide
• 05055343809655: Medium patella peg drill guide
• 05055343809648: Small patella peg drill guide
• 05055343808856: Patella presurisation clamp
• 05055343804346: Alignment guide rod
• 05055196975293: TIBIA BASEPLATE WITH LATCH
• 05055196975279: TIBIA BASEPLATE WITH LATCH
• 05055196975262: TIBIA BASEPLATE WITH LATCH
• 05055196975248: TIBIA BASEPLATE WITH LATCH
• 05055196975231: TIBIA BASEPLATE WITH LATCH
• 05055196975217: TIBIA BASEPLATE WITH LATCH
• 05055196975200: TIBIA BASEPLATE WITH LATCH
• 05055196975187: TIBIA BASEPLATE WITH LATCH
• 05055196975170: TIBIA BASEPLATE WITH LATCH
• 05055196975156: TIBIA BASEPLATE WITH LATCH
• 05055196968172: Tibial stylus
• 05055196967335: IM tibial resection jig
• 05055196966895: Distal resection block support arm
• 05055196966604: Spacer handle
• 05055196966598: 17 mm RTK+ spacer
• 05055196966581: 14.5 mm RTK+ spacer
• 05055196966574: 12 mm RTK+ spacer
• 05055196966567: 9.5 mm RTK+ spacer
• 05055196966550: 7 mm RTK+ spacer
• 05055196966406: 9º Bushing guide
• 05055196966390: 7º Bushing guide
• 05055196966383: 5º Bushing guide
• 05055196966376: 3º Bushing guide
• 05055196966345: Femoral introducer handle
• 05055196966314: IM rod
• 05055196965850: Tibial EM alignment guide
• 05055196965706: Tibial trial 17.0 mm mobile
• 05055196965690: Tibial trial 14.5 mm mobile
• 05055196965683: Tibial trial 12.0 mm mobile
• 05055196965676: Tibial trial 9.5 mm mobile
• 05055196965669: Tibial trial 7.0 mm mobile
• 05055196965584: Fixed bearing impactor
• 05055196960459: Posterior reference guide
• 05055196954649: Contents of pin box, consisting of:-
• 05055196954571: Angel wing