Ascential ACP 1 48803114A

GUDID 07613327122480

1 Level Anterior Cervical Plate

Stryker Corporation

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: 07613327122480
• NIH Device Record Key: dfa579df-651e-49fa-ba38-fc65e084fc42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascential ACP 1
• Version Model Number: 48803114A
• Catalog Number: 48803114A
• Company DUNS: 149183167
• Company Name: Stryker Corporation
• 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: true
• 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 Dimensions

• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327122480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150700

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-14

On-Brand Devices [Ascential ACP 1]

• 07613327122862: 4 Level Anterior Cervical Plate
• 07613327122855: 4 Level Anterior Cervical Plate
• 07613327122848: 4 Level Anterior Cervical Plate
• 07613327122831: 4 Level Anterior Cervical Plate
• 07613327122824: 4 Level Anterior Cervical Plate
• 07613327122817: 4 Level Anterior Cervical Plate
• 07613327122800: 4 Level Anterior Cervical Plate
• 07613327122794: 4 Level Anterior Cervical Plate
• 07613327122787: 4 Level Anterior Cervical Plate
• 07613327122770: 3 Level Anterior Cervical Plate
• 07613327122763: 3 Level Anterior Cervical Plate
• 07613327122756: 2 Level Anterior Cervical Plate
• 07613327122749: 3 Level Anterior Cervical Plate
• 07613327122732: 4 Level Anterior Cervical Plate
• 07613327122725: 4 Level Anterior Cervical Plate
• 07613327122718: 3 Level Anterior Cervical Plate
• 07613327122701: 3 Level Anterior Cervical Plate
• 07613327122695: 3 Level Anterior Cervical Plate
• 07613327122688: 3 Level Anterior Cervical Plate
• 07613327122671: 3 Level Anterior Cervical Plate
• 07613327122664: 2 Level Anterior Cervical Plate
• 07613327122657: 3 Level Anterior Cervical Plate
• 07613327122640: 2 Level Anterior Cervical Plate
• 07613327122633: 3 Level Anterior Cervical Plate
• 07613327122626: 3 Level Anterior Cervical Plate
• 07613327122619: 2 Level Anterior Cervical Plate
• 07613327122602: 2 Level Anterior Cervical Plate
• 07613327122596: 1 Level Anterior Cervical Plate
• 07613327122589: 2 Level Anterior Cervical Plate
• 07613327122572: 2 Level Anterior Cervical Plate
• 07613327122565: 2 Level Anterior Cervical Plate
• 07613327122558: 2 Level Anterior Cervical Plate
• 07613327122541: Variable Angle Self-Drilling Bone Screw Set
• 07613327122534: Locking Screw Sterile Packed
• 07613327122527: 1 Level Anterior Cervical Plate
• 07613327122510: 2 Level Anterior Cervical Plate
• 07613327122503: 1 Level Anterior Cervical Plate
• 07613327122497: 1 Level Anterior Cervical Plate
• 07613327122480: 1 Level Anterior Cervical Plate
• 07613327122473: 1 Level Anterior Cervical Plate
• 07613327122466: Variable Angle Self-Drilling Bone Screw Set
• 07613327122459: Variable Angle Self-Drilling Bone Screw Set
• 07613327122442: 1 Level Anterior Cervical Plate
• 07613327122435: Variable Angle Self-Drilling Bone Screw Set
• 07613327122428: Variable Angle Self-Drilling Bone Screw Set
• 07613327122411: Fixed Angle Self-Drilling Bone Screw Set
• 07613327122404: Fixed Angle Self-Drilling Bone Screw Set
• 07613327122398: Fixed Angle Self-Drilling Bone Screw Set
• 07613327122381: Variable Angle Self-Tapping Bone Screw Set
• 07613327122374: Fixed Angle Self-Drilling Bone Screw Set