Truliant CC 02-013-50-2512

GUDID 10885862626431

TRULIANT FIT AUGMENT TRIAL 1/2 RL SZ 2.5, 5MM

Exactech, Inc.

Knee tibia prosthesis trial, reusable

• Primary Device ID: 10885862626431
• NIH Device Record Key: c3f64a45-d679-46ff-91d8-0af2f60c0a53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Truliant CC
• Version Model Number: 02-013-50-2512
• Catalog Number: 02-013-50-2512
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862626431 [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: true
• Device Is Sterile: false

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

[10885862626431]

Moist Heat or Steam Sterilization

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