C-CURVE B20502183

GUDID 03613720275114

C-Curve° lordosable Ti 17x12x8mm

MEDICREA INTERNATIONAL

Metallic spinal interbody fusion cage

• Primary Device ID: 03613720275114
• NIH Device Record Key: e786a726-81c7-4752-83a6-4ce198ff6606
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-CURVE
• Version Model Number: B20502183
• Catalog Number: B20502183
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• 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	03613720275114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210470

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

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: 2021-10-15
• Device Publish Date: 2021-10-07

On-Brand Devices [C-CURVE]

• 03613720283621: C-CURVE SQUARED AWL
• 03613720283225: C-CURVE ANGLED SQUARED AWL
• 03613720282686: REMOVAL CLAMP C-CURVE
• 03613720281597: RATCHETING AO STRAIGHT HANDLE
• 03613720275695: C-Curve Screws Ø3.5mm x L13mmX2
• 03613720275688: C-Curve Screws Ø3.5mm x L15mmX2
• 03613720275671: C-Curve Screws Ø3.5mm x L17mmX2
• 03613720275664: MONOBLOC IMPLANT HOLDER WITH DRILL GUIDE C-CURVE H:7-8 mm
• 03613720275657: MONOBLOC IMPLANT HOLDER WITH DRILL GUIDE C-CURVE H:5-6 mm
• 03613720275244: C-Curve° lordosable Ti 19x14x7mm
• 03613720275152: C-Curve° lordosable Ti 19x14x8mm
• 03613720275145: C-Curve° lordosable Ti 19x14x6mm
• 03613720275138: C-Curve° lordosable Ti 19x14x5mm
• 03613720275114: C-Curve° lordosable Ti 17x12x8mm
• 03613720275107: C-Cure° lordosable Ti 17x12x7mm
• 03613720275091: C-Curve° lordosable Ti 17x12x6mm
• 03613720275084: C-Curve° lordosable Ti 17x12x5mm
• 03613720274445: FLEXIBLE SCREWDRIVER
• 03613720274346: SCREWDRIVER
• 03613720274322: GRAFT COMPACTOR
• 03613720274315: GRAFT SUPPORT
• 03613720274209: DOUBLE METALLIC TRIAL C-CURVE 19x14 mm H:7-8 mm
• 03613720274193: DOUBLE METALLIC TRIAL C-CURVE 19x14 mm H:5-6 mm
• 03613720274179: DOUBLE METALLIC TRIAL C-CURVE 17x12 mm H:7-8 mm
• 03613720274162: DOUBLE METALLIC TRIAL C-CURVE 17x12 mm H:5-6 mm
• 03613720287759: INSERT C-CURVE TRIALS
• 03613720287742: LID C-CURVE INSTRUMENTS TRAY
• 03613720287735: BASE C-CURVE INSTRUMENTS TRAY
• 03613720281955: INSERT C-CURVE TRIALS
• 03613720281948: LID C-CURVE INSTRUMENTS TRAY
• 03613720281924: BASE C-CURVE INSTRUMENTS TRAY