Truliant CC 02-012-65-9209

GUDID 10885862613745

TRULIANT CC TRANSITION POLY 2F TO 2.5T, 9MM

Exactech, Inc.

Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert

• Primary Device ID: 10885862613745
• NIH Device Record Key: 75762e13-6f2e-4ff5-b01e-47bfda8e6aa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Truliant CC
• Version Model Number: 02-012-65-9209
• Catalog Number: 02-012-65-9209
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• 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: true
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862613745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150890

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-17
• Device Publish Date: 2023-11-09

On-Brand Devices [Truliant CC]

• 10885862630186: TRULIANT 10 MM LONG IM PILOT DRILL WITH TROCAR TIP
• 10885862629852: TRULIANT STEM EXT TRIAL15MM X 120MM
• 10885862629753: TRULIANT STEM EXT TRIAL13MM X 120MM
• 10885862629647: TRULIANT STEM EXT TRIAL11MM X 120MM
• 10885862627964: TRULIANT FEMORAL OFFSET BUSHING GUIDE ADAPTER, SIZE 5
• 10885862627957: TRULIANT FEMORAL OFFSET BUSHING GUIDE ADAPTER, SIZE 4
• 10885862627940: TRULIANT FEMORAL OFFSET BUSHING GUIDE ADAPTER, SIZE 3
• 10885862627933: TRULIANT FEMORAL OFFSET BUSHING GUIDE ADAPTER, SIZE 2
• 10885862627926: TRULIANT FEMORAL OFFSET BUSHING GUIDE ADAPTER, SIZE 1
• 10885862627919: TRULIANT DISTAL FEMORAL VALGUS COUPLER
• 10885862627681: TRULIANT STEM EXTENSION IMPLANT RECOVERY TOOL
• 10885862627674: TRULIANT INTRAMEDUALLY TIBIAL GUIDE
• 10885862627483: TRULIANT SIZING TEMPLATE IM GUIDE
• 10885862627476: TRULIANT FEMORAL OFFSET BUSHING GUIDE
• 10885862627469: TRULIANT STEM EXTENSION TRIAL RECOVERY TOOL
• 10885862627452: TRULIANT FEMORAL BOSS PREP REAMER
• 10885862627445: TRULIANT TIBIAL OFFSET PREP REAMER
• 10885862627438: TRULIANT FEMORAL OFFSET PREP REAMER
• 10885862627421: TRULIANT 15MM REAMER
• 10885862627414: TRULIANT 13MM REAMER
• 10885862627407: TRULIANT 11MM REAMER
• 10885862627377: TRULIANT 6MM OFFSET BUSHING
• 10885862627360: TRULIANT 4MM OFFSET BUSHING
• 10885862627353: TRULIANT 2MM OFFSET BUSHING
• 10885862627346: TRULIANT 0MM OFFSET BUSHING
• 10885862627339: TRULIANT CC NOTCH GUIDE, SIZE 5
• 10885862627322: TRULIANT CC NOTCH GUIDE, SIZE 4
• 10885862627315: TRULIANT CC NOTCH GUIDE, SIZE 3
• 10885862627308: TRULIANT CC NOTCH GUIDE, SIZE 2
• 10885862627292: TRULIANT CC NOTCH GUIDE, SIZE 1
• 10885862627230: TRULIANT CC TRIAL EXTRACTOR
• 10885862627223: TRULIANT SIZING TEMPLATE SIZE 5
• 10885862627216: TRULIANT SIZING TEMPLATE SIZE 4
• 10885862627209: TRULIANT SIZING TEMPLATE SIZE 3
• 10885862627193: TRULIANT SIZING TEMPLATE SIZE 2
• 10885862627186: TRULIANT SIZING TEMPLATE SIZE 1
• 10885862627162: TRULIANT 24MM REAMER
• 10885862627155: TRULIANT 22MM REAMER
• 10885862627148: TRULIANT 20MM REAMER
• 10885862627131: TRULIANT 18MM REAMER
• 10885862627124: TRULIANT 16MM REAMER
• 10885862627117: TRULIANT 14MM REAMER
• 10885862627100: TRULIANT 12MM REAMER
• 10885862627094: TRULIANT 10MM REAMER
• 10885862627087: TRULIANT OFFSET STEM EXT COUPLER TRIAL, 8MM
• 10885862627070: TRULIANT OFFSET STEM EXT COUPLER TRIAL, 6MM
• 10885862627063: TRULIANT OFFSET STEM EXT COUPLER TRIAL, 4MM
• 10885862627056: TRULIANT OFFSET STEM EXT COUPLER TRIAL, 2MM
• 10885862627049: TRULIANT STEM EXT TRIAL 24MM X 80MM
• 10885862627032: TRULIANT STEM EXT TRIAL 24MM X 160MM