Aptitude Anterior Cervical Plate System

GUDID B648C16401220

Midline Anterior Cervical Plate, One-Level, 22mm

CURITEVA, INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: B648C16401220
• NIH Device Record Key: 99068751-dc9d-431f-b2e2-dce839eedcbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aptitude Anterior Cervical Plate System
• Version Model Number: C164-01-22
• 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: true
• 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

• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B648C16401220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181549

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

[B648C16401220]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-17
• Device Publish Date: 2019-01-04

On-Brand Devices [Aptitude Anterior Cervical Plate System]

• B648C16402420: Midline Anterior Cervical Plate, Two-Level, 42mm
• B648C16402400: Midline Anterior Cervical Plate, Two-Level, 40mm
• B648C16402380: Midline Anterior Cervical Plate, Two-Level, 38mm
• B648C16402360: Midline Anterior Cervical Plate, Two-Level, 36mm
• B648C16402340: Midline Anterior Cervical Plate, Two-Level, 34mm
• B648C16402320: Midline Anterior Cervical Plate, Two-Level, 32mm
• B648C16402300: Midline Anterior Cervical Plate, Two-Level, 30mm
• B648C16402280: Midline Anterior Cervical Plate, Two-Level, 28mm
• B648C16402260: Midline Anterior Cervical Plate, Two-Level, 26mm
• B648C16401260: Midline Anterior Cervical Plate, One-Level, 26mm
• B648C16401240: Midline Anterior Cervical Plate, One-Level, 24mm
• B648C16401220: Midline Anterior Cervical Plate, One-Level, 22mm
• B648C16401200: Midline Anterior Cervical Plate, One-Level, 20mm
• B648C16401180: Midline Anterior Cervical Plate, One-Level, 18mm
• B648C16401160: Midline Anterior Cervical Plate, One-Level, 16mm
• B648C16401140: Midline Anterior Cervical Plate, One-Level, 14mm
• B648C16401120: Midline Anterior Cervical Plate, One-Level, 12mm
• B648C1544518VST0: Variable Self-Tapping Rescue Screw, 4.5 x 18mm
• B648C1544518FST0: Fixed Self-Tapping Rescue Screw, 4.5 x 18mm
• B648C1544516VST0: Variable Self-Tapping Rescue Screw, 4.5 x 16mm
• B648C1544516FST0: Fixed Self-Tapping Rescue Screw, 4.5 x 16mm
• B648C1544514VST0: Variable Self-Tapping Rescue Screw, 4.5 x 14mm
• B648C1544514FST0: Fixed Self-Tapping Rescue Screw, 4.5 x 14mm
• B648C1544512VST0: Variable Self-Tapping Rescue Screw, 4.5 x 12mm
• B648C1544512FST0: Fixed Self-Tapping Rescue Screw, 4.5 x 12mm
• B648C1544018VST0: Variable Self-Tapping Screw, 4.0 x 18mm
• B648C1544018VSD0: Variable Self-Drilling Screw, 4.0 x 18mm
• B648C1544018FST0: Fixed Self-Tapping Screw, 4.0 x 18mm
• B648C1544018FSD0: Fixed Self-Drilling Screw, 4.0 x 18mm
• B648C1544016VST0: Variable Self-Tapping Screw, 4.0 x 16mm
• B648C1544016VSD0: Variable Self-Drilling Screw, 4.0 x 16mm
• B648C1544016FST0: Fixed Self-Tapping Screw, 4.0 x 16mm
• B648C1544016FSD0: Fixed Self-Drilling Screw, 4.0 x 16mm
• B648C1544014VST0: Variable Self-Tapping Screw, 4.0 x 14mm
• B648C1544014VSD0: Variable Self-Drilling Screw, 4.0 x 14mm
• B648C1544014FST0: Fixed Self-Tapping Screw, 4.0 x 14mm
• B648C1544014FSD0: Fixed Self-Drilling Screw, 4.0 x 14mm
• B648C1544012VST0: Variable Self-Tapping Screw, 4.0 x 12mm
• B648C1544012VSD0: Variable Self-Drilling Screw, 4.0 x 12mm
• B648C1544012FST0: Fixed Self-Tapping Screw, 4.0 x 12mm
• B648C1544012FSD0: Fixed Self-Drilling Screw, 4.0 x 12mm
• B648C15404840: Anterior Cervical Plate, Four-Level, 84mm
• B648C15404800: Anterior Cervical Plate, Four-Level, 80mm
• B648C15404760: Anterior Cervical Plate, Four-Level, 76mm
• B648C15404720: Anterior Cervical Plate, Four-Level, 72mm
• B648C15404680: Anterior Cervical Plate, Four-Level, 68mm
• B648C15404640: Anterior Cervical Plate, Four-Level, 64mm
• B648C15404600: Anterior Cervical Plate, Four-Level, 60mm
• B648C15403630: Anterior Cervical Plate, Three-Level, 63mm
• B648C15403600: Anterior Cervical Plate, Three-Level, 60mm