Product code NDN— Orthopedic
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
- Advisory panel
- Orthopedic
- Total cleared
- 108
Adverse events under product code NDN
product code NDN- Death
- 24
- Injury
- 407
- Malfunction
- 1,975
- Total
- 2,406
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NDN
1–100 of 108- K251896 — XeliteMed SuperM-Fix Spinal Bone Cement
- K250637 — VCFix Spinal System
- K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
- K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement
- K232842 — Balloon Inflation System
- K240084 — V-STRUT® Vertebral Implant
- K231340 — Renova Spine Balloon Catheter
- K221697 — INJECTION PIN (KIP(02031-02061) (03031-03061))
- K223294 — SpineJack® Expansion Kit
- K220131 — KYPHON VuE Bone Cement
- K211797 — TRACKER Plus Kyphoplasty System
- K211238 — SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
- K202393 — SpineJack Expansion Kit
- K201831 — CONFIDENCE Spinal Cement System
- K192449 — Joline Kyphoplasty System Allevo
- K191709 — V-STRUT Vertebral Implant
- K192335 — TRACKER Kyphoplasty System
- K192403 — VK100 Percutaneous Vertebral Augmentation System
- K181262 — SpineJack Expansion Kit
- K172871 — SpineKure Kyphoplasty System
- K180700 — KYPHON HV-R Bone Cement
- K172214 — Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
- K161114 — HIGH V+
- K163032 — Kyphon Xpede Bone Cement
- K162283 — DCM Kyphoplasty System
- K162618 — CONCORD Plus Radiopaque Bone Cement
- K162453 — 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
- K160983 — Kyphon HV-R Bone Cement
- K153296 — MEDINAUT Kyphoplasty System
- K152557 — Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
- K151227 — KYPHON XPEDE Bone Cement
- K150582 — Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
- K150460 — KYPHON (R) HV-R(R) Bone Cement
- K150607 — Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
- K150322 — InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)
- K143006 — GUARDIAN-SG Inflatable Bone Expander System
- K141419 — ZVPLASTY
- K141930 — OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
- K141141 — KIVA VCF TREATMENT SYSTEM
- K140937 — OSSEOFLEX SB
- K132620 — INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
- K133669 — MEDINAUT KYPHOPLASTY SYSTEM
- K132817 — KIVA VCF TREATMENT SYSTEM
- K133372 — CROSSTREES PVA POD
- K130089 — CROSSTREES PVA POD
- K122503 — PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
- K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
- K123942 — STRYKER IVAS BALLOON CATHETER
- K130402 — SPIDER SYSTEM KOLIBRI CEMENT NEEDLE
- K122175 — MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
- K100404 — ASCENDX VCF REDUCTION SYSTEM
- K122533 — OSSEOFLEX SB INFLATABLE BONE TAMP
- K121876 — VERTECEM II CEMENT KIT
- K113742 — KMC KYPHOPLASTY SYSTEM
- K113452 — ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
- K113154 — IVAS BALLOON CATHETER
- K113477 — IVAS 20MM (10 GAUGE) BALLOON CATHETER
- K112907 — CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
- K110604 — VBB SYSTEM
- K093477 — SHIELD KYPHOPLASTY SYSTEM
- K111593 — GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
- K110998 — AFFIRM (TM) VCF SYSTEM
- K103807 — IVAS 2-10MM (10 GUAGE) BALLON CATHETER
- K102397 — KYPHON XPEDE BONE CEMENT
- K110183 — ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
- K103816 — COHESION BONE CEMENT
- K103064 — AVAMAX VERTEBRAL BALLOON
- K103433 — F20
- K100479 — PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
- K093828 — KYPH X HV-R BONE CEMENT
- K093419 — IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS
- K093463 — AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
- K091234 — SKELTEX ISV
- K090986 — STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)
- K090435 — VERTECEM
- K091606 — VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
- K090211 — INFLATABLE BONE TAMP
- K080108 — CORTOSS BONE AUGMENTATION MATERIAL
- K090460 — BONOS INJECT
- K080873 — OPACITY + BONE CEMENT
- K071375 — MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
- K072118 — STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT
- K071927 — MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
- K072133 — AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
- K072496 — MODIFICATION TO SPACE CPSXL BONE CEMENT
- K070351 — SPACE 360 DELIVERY SYSTEM
- K070527 — ARCUATE VERTEBRAL AUGMENTATION SYSTEM
- K063248 — ARCUATE VERTEBRAL AUGMENTATION SYSTEM
- K063438 — VSPSPN
- K063067 — CONFIDENCE FENESTRATED INTRODUCER NEEDLE
- K062452 — KIT MENDEC SPINE AND DELIVERY SYSTEM
- K062424 — CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
- K061531 — SPACE CPSXL BONE CEMENT
- K060425 — PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
- K053336 — STAXX FX SYSTEM
- K060300 — CONFIDENCE HIGH VISCOSITY BONE CEMENT
- K043593 — SPINE-FIX BIOMIMETIC BONE CEMENT
- K060148 — EBI VERTEBROPLASTY SYSTEMS
- K053180 — PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS
- K042691 — VERTEFIX VERTEBROPLASTY PROCEDURE SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.