Asfora Bullet Cage® System

GUDID M364119902FD70

16mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.

MEDICAL DESIGNS LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M364119902FD70
• NIH Device Record Key: bf71b567-7dc8-4d19-9603-955f3f958dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Asfora Bullet Cage® System
• Version Model Number: 11-9902-FD7
• Company DUNS: 003815548
• Company Name: MEDICAL DESIGNS LLC
• 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: 605-275-1032
• Email: kspielman@medicaldeisgnsllc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M364119902FD70 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

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: 2020-02-24
• Device Publish Date: 2016-09-27

On-Brand Devices [Asfora Bullet Cage® System ]

• 1199029: 18mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
• 1199028: 16mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
• M364119902FD70: 16mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
• 1199026: 14mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
• 1199025: 14mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
• 1199024: 12mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
• 1199023: 12mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
• 1199022: 10mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
• 11990210: 18mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
• M364119902FD10: 10mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal