In2Bones USA

GUDID 00810021862033

CoLink CFX MIS Plate, Ext, Large, Left

IN2BONES USA, LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00810021862033
• NIH Device Record Key: 7dff7899-af9a-413d-ae61-94f0e4e97d51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: In2Bones USA
• Version Model Number: P80 ST222
• Company DUNS: 079700711
• Company Name: IN2BONES USA, LLC
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810021862033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200762

FDA Product Code

• HRS: Plate, Fixation, Bone

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: 2020-09-14
• Device Publish Date: 2020-09-04

On-Brand Devices [In2Bones USA]

• 00817906029994: Lag Screw Countersink, 2.0/2.5
• 00817906029987: Lag Screw Drill, Cannulated 1.6
• 00817906029970: Lag Screw Driver, T7 Cannulated
• 00817906029963: LAG SCREW COUNTERSINK, HUDSON, Ø5.0
• 00817906029956: LAG SCREW DRILL, CANNULATED, HUDSON, Ø4.8
• 00817906029949: LAG SCREW DRILL, CANNULATED, HUDSON, Ø3.3
• 00817906029932: K-WIRE, S. TROCAR, SMOOTH, .031X4"
• 00817906029925: LAG SCREW COUNTERSINK, Ø6.7
• 00817906029918: LAG SCREW COUNTERSINK, Ø4.0/Ø5.0
• 00817906029901: LAG SCREW COUNTERSINK, Ø3.0
• 00817906029895: LAG SCREW DRILL, CANNULATED, Ø4.8
• 00817906029888: LAG SCREW DRILL, CANNULATED, Ø3.3
• 00817906029871: LAG SCREW DRILL, CANNULATED, Ø2.7
• 00817906029864: LAG SCREW DRILL, CANNULATED, Ø2.1
• 00817906029857: LAG SCREW DRIVER, T15, CANNULATED
• 00817906029840: LAG SCREW DRIVER, T8, CANNULATED
• 00817906029833: K-WIRE, S. TROCAR, SMOOTH, .087X7"
• 00817906029826: K-WIRE, S. TROCAR, SMOOTH, .062X6"
• 00817906029819: K-WIRE, S. TROCAR, SMOOTH, .062X7"
• 00817906029802: K-WIRE, S. TROCAR, SMOOTH, .062X5"
• 00817906029796: K-WIRE, S. TROCAR, SMOOTH, .045X6"
• 00817906029789: K-WIRE, S. TROCAR, SMOOTH, .045X5"
• 00817906029772: 1.6MMX9" SINGLE TROCAR, SMOOTH, K-WIRE
• 00817906029765: 2.2MMX9" SINGLE TROCAR, SMOOTH, STEINMANN PIN
• 00817906029758: 5MS, JONES SCREW TAP, Ø6.0
• 00817906029741: 5MS, JONES SCREW TAP, Ø5.5
• 00817906029734: 5MS, JONES SCREW TAP, Ø4.5
• 00817906029727: 5MS, CANNULATED JONES DRILL, Ø4.5
• 00817906029710: 5MS, CANNULATED JONES DRILL, Ø3.5
• 00817906029703: 5MS, SMALL SCREW DRILL, Ø1.9
• 00817906029697: 5MS, SMALL SCREW DRILL, Ø1.6
• 00817906029680: 5MS, T25 DRIVER, CANNULATED, AO
• 00817906029673: 5MS, T15 DRIVER, CANNULATED, AO
• 00817906029666: 5MS, T7 DRIVER, SOLID, AO
• 00817906029659: 2.5 mm Drill Bit
• 00817906029642: 2.0 mm Drill Bit
• 00817906029635: Olive Wire .045 x 2.5"
• 00817906029628: T-8 Driver Bit
• 00817906029611: T-8 Driver Bit
• 00817906029604: Reamer, 2.9 mm Diameter, Non-Sterile
• 00817906029598: Reamer, 2.4 mm Diameter, Non-Sterile
• 00817906029581: .045 x 4.0 in. K-wire, double diamond, Non-Sterile
• 00810021861302: AFX, Lag Guide, Ø1.9
• 00810021861296: AFX, Lag Guide, Ø2.5
• 00810021861289: NL Drill Guide, 2.5 & 3.5, Assy
• 00810021861272: NL Drill Guide, 1.9 & 2.7, Assy
• 00810021861265: Lag Screw Sizer, X-Small
• 00810021861258: LAG SCREW SIZER, 9" WIRE
• 00810021861241: LAG SCREW SIZER, 6" WIRE
• 00810021861234: LAG SCREW WIRE GUIDE, Ø6.7