Vault C ACDF System 37-CL-4208

GUDID 00840019904346

14 x 12 x 08mm 7° Posterior Cage

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840019904346
• NIH Device Record Key: 73f933c1-f785-4c6f-9d56-735cab810010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vault C ACDF System
• Version Model Number: 37-CL-4208
• Catalog Number: 37-CL-4208
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019904346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132029

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[00840019904346]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-04-05

On-Brand Devices [Vault C ACDF System]

• 00840019917254: Implant Insertion Tip Caddy
• 00840019917230: Instrument Sterilization Case
• 00840019917223: Implant Sterilization Case Assembly (All Caddies Included)
• 00840019917216: Implant - Screw Caddy
• 00840019917209: Implant - 18 x 15 Caddy
• 00840019917193: Implant - 16 x 14 Caddy
• 00840019917186: Implant - 14 x 12 Caddy
• 00840019917179: Implant Sterilization Case
• 00840019917148: Cage Inserter
• 00840019917124: Torque Locking Handle
• 00840019917117: Angled Bone Drill - 12mm
• 00840019917100: Angled Self-Retaining Driver (2)
• 00840019917056: Drill Guide
• 00840019917049: Angled Awl
• 00840019917032: Freehand Drill Guide
• 00840019917025: Straight Awl
• 00840019917018: Impaction/Extraction Mallet
• 00840019917001: Implant Extraction Hook
• 00840019916998: Bone Graft Compactor
• 00840019916981: Implant Assembly Block
• 00840019916974: Self-Retaining Drivers (2)
• 00840019916967: Implant Insertion Tamp
• 00840019916950: Guided Insertion Tip - 12mm
• 00840019916943: Guided Insertion Tip - 11mm
• 00840019916905: Guided Insertion Tip - 07mm
• 00840019916899: Guided Insertion Tip - 06mm
• 00840019916875: Implant Insertion Handle
• 00840019916868: Rasp, 7° Lordosis, 18x15 - 11/12mm
• 00840019916851: Rasp, 7° Lordosis, 18x15 - 9/10mm
• 00840019916844: Rasp, 7° Lordosis, 18x15 - 7/8mm
• 00840019916837: Rasp, 7° Lordosis, 18x15 - 5/6mm
• 00840019916820: Rasp, 7° Lordosis, 16x14 - 11/12mm
• 00840019916813: Rasp, 7° Lordosis, 16x14 - 9/10mm
• 00840019916806: Rasp, 7° Lordosis, 16x14 - 7/8mm
• 00840019916769: Rasp, 7° Lordosis, 14x12 - 7/8mm
• 00840019916752: Rasp, 7° Lordosis, 14x12 - 5/6mm
• 00840019916745: Rasp, 0° Lordosis, 18x15 - 11/12mm
• 00840019916738: Rasp, 0° Lordosis, 18x15 - 9/10mm
• 00840019916714: Rasp, 0° Lordosis, 18x15 - 5/6mm
• 00840019916707: 37-RS-0612
• 00840019916691: Rasp, 0° Lordosis, 16x14 - 9/10mm
• 00840019916684: Rasp, 0° Lordosis, 16x14 - 7/8mm
• 00840019916677: Rasp, 0° Lordosis, 16x14 - 5/6mm
• 00840019916653: Rasp, 0° Lordosis, 14x12 - 9/10mm
• 00840019916639: Rasp, 0° Lordosis, 14x12 - 5/6mm
• 00840019916608: Trial, 7° Lordosis, 18x15 - 7/8mm
• 00840019916592: Trial, 7° Lordosis, 18x15 - 5/6mm
• 00840019916585: Trial, 7° Lordosis, 16x14 - 11/12mm
• 00840019916578: Trial, 7° Lordosis, 16x14 - 9/10mm
• 00840019916561: Trial, 7° Lordosis, 16x14 - 7/8mm