NDN — Cement, Bone, Vertebroplasty

21 CFR 888.3027

Class 2 Implant
Medical Specialty

OR

Review Panel

OR

Submission Type

1

FDA Authorisations (108)

Device Name K-Number
XeliteMed SuperM-Fix Spinal Bone Cement K251896
VCFix Spinal System K250637
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System K243537
XeliteMed VertehighFix High Viscosity Spinal Bone Cement K241775
Balloon Inflation System K232842
V-STRUT® Vertebral Implant K240084
Renova Spine Balloon Catheter K231340
INJECTION PIN (KIP(02031-02061) (03031-03061)) K221697
SpineJack® Expansion Kit K223294
KYPHON VuE Bone Cement K220131
TRACKER Plus Kyphoplasty System K211797
SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement K211238
SpineJack Expansion Kit K202393
CONFIDENCE Spinal Cement System K201831
Joline Kyphoplasty System Allevo K192449
V-STRUT Vertebral Implant K191709
TRACKER Kyphoplasty System K192335
VK100 Percutaneous Vertebral Augmentation System K192403
SpineJack Expansion Kit K181262
SpineKure Kyphoplasty System K172871
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