Uniglide Unicondylar Knee Prosthesis BC8K-2LO2-000

GUDID 05055196914452

TIBIAL CUTTING BLOCK ASSEMBLY

CORIN LTD

Orthopaedic implant aiming/guiding block, reusable

• Primary Device ID: 05055196914452
• NIH Device Record Key: 7faa1d75-70b0-446a-92a4-e6762ffb769f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uniglide Unicondylar Knee Prosthesis
• Version Model Number: BC8K-2LO2-000
• Catalog Number: BC8K-2LO2-000
• Company DUNS: 295437313
• Company Name: CORIN LTD
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	05055196914452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050764

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[05055196914452]

Moist Heat or Steam 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 [Uniglide Unicondylar Knee Prosthesis]

• 05055343821404: AMC UNI FIXED TRIAL INTRODUCER FORCEPS
• 05055196940253: REFERENCE GUIDE ARM
• 05055196914612: DAILLABLE STYLUS
• 05055196914520: UNIGLIDE TIBIAL FIXED KEEL PUNCH SIZE 7
• 05055196914513: UNIGLIDE TIBIAL FIXED KEEL PUNCH SIZE 5
• 05055196914506: UNIGLIDE TIBIAL FIXED KEEL PUNCH SIZE 3
• 05055196914452: TIBIAL CUTTING BLOCK ASSEMBLY
• 05055196914445: TIBIAL CUTTING BLOCK ASSEMBLY
• 05055196909205: BURR TOOL
• 05055196909199: STARTER REAMER
• 05055196909182: UNIGLIDE FIXED TIBIA TRIAL SIZE 3 13MM
• 05055196909175: UNIGLIDE FIXED TIBIA TRIAL SIZE 3 11 MM
• 05055196909168: UNIGLIDE FIXED TIBIA TRIAL SIZE 3 9MM
• 05055196909151: UNIGLIDE FIXED TIBIA TRIAL SIZE 3 -7MM
• 05055196909144: UNIGLIDE FIXED TIBIA TRIAL SIZE 5-13MM
• 05055196909137: UNIGLIDE FIXED TIBIA TRIAL SIZE 5 -11MM
• 05055196909120: UNIGLIDE FIXED TIBIA TRIAL SIZE 5 -9 MM
• 05055196909113: UNIGLIDE FIXED TIBIA TRIAL SIZE 5 -7 MM
• 05055196909106: UNIGLIDE FIXED TIBIA TRIAL SIZE 7- 13MM
• 05055196909090: UNIGLIDE FIXED TIBIA TRIAL SIZE7- 11MM
• 05055196909083: UNIGLIDE FIXED TIBIA TRIAL SIZE 7 -9 MM
• 05055196909076: UNIGLIDE FIXED TIBIA TRIAL SIZE 7- 7MM
• 05055196909014: TIBIAL ALIGNMENT JIG
• 05055196909007: SPHERICAL REAMER- 14 MM SPANNER
• 05055196908994: SPERICAL REAMER-12MM SPANNER
• 05055196908956: FEMORAL DRILL 5 MM
• 05055196908949: FEMORAL DRILL 3MM
• 05055196908932: FEMORAL TRIAL SIZE 4 WITH SLOT
• 05055196908925: FEMORAL TRIAL SIZE 3 WITH SLOT
• 05055196908918: FEMORAL TRIAL SIZE 2 WITH SLOT
• 05055196908901: SPHERICAL REAMER- SIZE 4
• 05055196908895: SPHERICAL REAMER- SIZE 3
• 05055196908888: SPHERICAL REAMER- SIZE 2
• 05055196908871: FEMORAL TOWER ALIGNMENT PIN
• 05055196908659: UNIGLIDE FIXED TRIAL SIZE 5-13
• 05055196908642: UNIGLIDE FIXED TRIAL SIZE 5-11
• 05055196908635: UNIGLIDE FIXED TRIAL SIZE 5-9
• 05055196908628: UNIGLIDE FIXED BEARING TRIAL SIZE 5-7
• 05055196908345: FEMORAL SLOT PUNCH
• 05055196908338: FEMORAL SIZER TEMPLATE- SIZES 3 & 4
• 05055196908321: FEMORAL SIZER TEMPLATE SIZES 1 & 2
• 05055196908284: TIBIAL FIXED TEMPLATE TRIAL SIZE 7
• 05055196908277: TIBIAL FIXED TEMPLATE TRIAL SIZE 5
• 05055196908260: TIBIAL FIXED TEMPLATE TRIAL SIZE 3
• 05055196908185: SIZER & PLACEMENT GUIDE FOR TIBIAL BASE
• 05055196908123: C-ARM IMPACTOR
• 05055196908116: FEMORAL ALIGNMENT TOWER
• 05055196908109: FEMORAL CUTTING BLOCK- SIZE 4
• 05055196908093: FEMORAL CUTTING BLOCK- SIZE 3
• 05055196908086: FEMORAL CUTTING BLOCK- SIZE 2