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 IDM364119902FD70
NIH Device Record Keybf71b567-7dc8-4d19-9603-955f3f958dc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAsfora Bullet Cage® System
Version Model Number11-9902-FD7
Company DUNS003815548
Company NameMEDICAL DESIGNS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone605-275-1032
Emailkspielman@medicaldeisgnsllc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM364119902FD70 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-24
Device Publish Date2016-09-27

On-Brand Devices [Asfora Bullet Cage® System ]

119902918mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
119902816mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
M364119902FD7016mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
119902614mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
119902514mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
119902412mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
119902312mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
119902210mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
1199021018mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal
M364119902FD1010mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletal

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