Prowess Laminoplasty System

GUDID B648C10556030

10mm SPACER TRIAL

CURITEVA, INC.

Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: B648C10556030
• NIH Device Record Key: b5078a72-3872-4be3-a3a3-b852e0b51bd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prowess Laminoplasty System
• Version Model Number: C1055-603
• Company DUNS: 074575332
• Company Name: CURITEVA, 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

Customer Support Contacts

• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com

Device Dimensions

• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B648C10556030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191810

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

[B648C10556030]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-15
• Device Publish Date: 2024-01-05

On-Brand Devices [Prowess Laminoplasty System]

• B648C1054404P0: PEEK Spacer, 4mm
• B648C10542304SD0: Self-Drilling Screw, 2.3 x 4mm
• B648C1054104N0: Spacer Plate, Inline, 4mm
• B648C1054412P0: PEEK Spacer, 12mm
• B648C1054410P0: PEEK Spacer, 10mm
• B648C1054408P0: PEEK Spacer, 8mm
• B648C1054406P0: PEEK Spacer, 6mm
• B648C10543SS0: Hinge Plate, Side by Side
• B648C10543N0: Hinge Plate, Inline
• B648C10542712ST0: Self-Tapping Screw, 2.7 x 12mm
• B648C10542710ST0: Self-Tapping Screw, 2.7 x 10mm
• B648C10542708ST0: Self-Tapping Screw, 2.7 x 8mm
• B648C10542706ST0: Self-Tapping Screw, 2.7 x 6mm
• B648C10542704ST0: Self-Tapping Screw, 2.7 x 4mm
• B648C10542312ST0: Self-Tapping Screw, 2.3 x 12mm
• B648C10542312SD0: Self-Drilling Screw, 2.3 x 12mm
• B648C10542310ST0: Self-Tapping Screw, 2.3 x 10mm
• B648C10542310SD0: Self-Drilling Screw, 2.3 x 10mm
• B648C10542308ST0: Self-Tapping Screw, 2.3 x 8mm
• B648C10542308SD0: Self-Drilling Screw, 2.3 x 8mm
• B648C10542306ST0: Self-Tapping Screw, 2.3 x 6mm
• B648C10542306SD0: Self-Drilling Screw, 2.3 x 6mm
• B648C10542304ST0: Self-Tapping Screw, 2.3 x 4mm
• B648C1054112SS0: Spacer Plate, Side by Side, 12mm
• B648C1054112N0: Spacer Plate, Inline, 12mm
• B648C1054110SS0: Spacer Plate, Side by Side, 10mm
• B648C1054110N0: Spacer Plate, Inline, 10mm
• B648C1054108SS0: Spacer Plate, Side by Side, 8mm
• B648C1054108N0: Spacer Plate, Inline, 8mm
• B648C1054106SS0: Spacer Plate, Side by Side, 6mm
• B648C1054106N0: Spacer Plate, Inline, 6mm
• B648C1054104SS0: Spacer Plate, Side by Side, 4mm
• B648C10558100: IMPLANT PICKUP
• B648C10558000: PLATE-SPACER INSERTER
• B648C10557000: PLATE-SPACER ASSEMBLY BLOCK
• B648C10556040: 12mm SPACER TRIAL
• B648C10556030: 10mm SPACER TRIAL
• B648C10556020: 8mm SPACER TRIAL
• B648C10556010: 6mm SPACER TRIAL
• B648C10556000: 4mm SPACER TRIAL
• B648C10555000: SCREW DRIVER
• B648C10554100: 1.25 x 4MM FLAT END BONE AWL
• B648C10554000: 1.25 x 4MM BONE AWL
• B648C1055300100: 10mm DRILL
• B648C1055300080: 8mm DRILL
• B648C1055300060: 6mm DRILL
• B648C1055300040: 4mm DRILL
• B648C10552100: Plate Cutter
• B648C10552000: Plate Bender
• B648C10551100: LAMINA LIFTER