VFT VF3316P

GUDID 03662663025614

LDR Spine Usa, Inc.

Vertebral body prosthesis

• Primary Device ID: 03662663025614
• NIH Device Record Key: c01a06f2-78d3-4da6-9cc5-05832806d8fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VFT
• Version Model Number: VF3316P
• Catalog Number: VF3316P
• Company DUNS: 615789729
• Company Name: LDR Spine Usa, 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: true
• 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: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com

Device Dimensions

• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter
• Height: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663025614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162133

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-05-19

On-Brand Devices [VFT]

• 03662663025836: VF3338P
• 03662663025829: VF3337P
• 03662663025812: VF3336P
• 03662663025805: VF3335P
• 03662663025799: VF3334P
• 03662663025782: VF3333P
• 03662663025775: VF3332P
• 03662663025768: VF3331P
• 03662663025751: VF3330P
• 03662663025744: VF3329P
• 03662663025737: VF3328P
• 03662663025720: VF3327P
• 03662663025713: VF3326P
• 03662663025706: VF3325P
• 03662663025690: VF3324P
• 03662663025683: VF3323P
• 03662663025676: VF3322P
• 03662663025669: VF3321P
• 03662663025652: VF3320P
• 03662663025645: VF3319P
• 03662663025638: VF3318P
• 03662663025621: VF3317P
• 03662663025614: VF3316P
• 03662663025607: VF3315P
• 03662663025591: VF3314P
• 03662663025584: VF3313P
• 03662663025577: VF3312P
• 03662663025560: VF3311P
• 03662663025553: VF3310P
• 03662663025546: VF3309P
• 03662663025539: VF3308P
• 03662663025522: VF3307P
• 03662663025515: VF3306P
• 03662663025508: VF3305P
• 03662663025492: VF3304P
• 03662663025485: VF3303P
• 03662663025478: VF3302P
• 03662663025461: VF3301P
• 03662663025454: VF2331P
• 03662663025447: VF2330P
• 03662663025430: VF2329P
• 03662663025423: VF2328P
• 03662663025416: VF2327P
• 03662663025409: VF2326P
• 03662663025393: VF2325P
• 03662663025386: VF2324P
• 03662663025379: VF2323P
• 03662663025362: VF2322P
• 03662663025355: VF2321P
• 03662663025348: VF2320P