NDN

Product Code: NDN


Products Classified as NDN

4640Cement, Bone, VertebroplastyPolymethylmethacrylate (PMMA) Bone Cement.

Total Product Life Cycle (TPLC) Devices

4640Cement, Bone, VertebroplastyPolymethylmethacrylate (PMMA) Bone Cement.

FDA Consensus Standards

Cement, Bone, Vertebroplasty [37410]21 CFR §888.3027 🔎
Cement, Bone, Vertebroplasty [37411]21 CFR §888.3027 🔎
Cement, Bone, Vertebroplasty [35609]21 CFR §888.3027 🔎

Pre-market Notifications for NDN

K220131KYPHON VuE Bone CementTecres S.p.A.
K211797TRACKER Plus Kyphoplasty SystemGS Medical Co. Ltd.
K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone CementStryker Instruments
K192449Joline Kyphoplasty System AllevoJoline GmbH & Co. KG
K192403VK100 Percutaneous Vertebral Augmentation SystemBONWRx Ltd
K192335TRACKER Kyphoplasty SystemGS Medical Co., Ltd.
K191709V-STRUT Vertebral ImplantHyprevention SAS
K181262SpineJack Expansion KitVexim SA
K180700KYPHON HV-R Bone CementMedtronic Sofamor Danek USA, Inc.
K172871SpineKure Kyphoplasty SystemHanchang Co., Ltd.
K172214Modified Winch Kyphoplasty (15 And 20 Mm) 11 Gauge Balloon CathetersG-21 S.r.l.
K163032Kyphon Xpede Bone CementMedtronic Inc.
K162618CONCORD Plus Radiopaque Bone CementGLOBUS MEDICAL, INC.
K16245313G InterV Kyphoplasty Catheter (Micro) And 11G InterV Kyphoplasty Catheter (Mini-Flex)Pan Medical Ltd.
K162283DCM Kyphoplasty SystemDragon Crown Medical Co., Ltd.

Global Unique Device Identification Database

00376017704882CEMENT, BONE, VERTEBROPLASTY
00613994831507CEMENT, BONE, VERTEBROPLASTY
00613994746931CEMENT, BONE, VERTEBROPLASTY
00613994745606CEMENT, BONE, VERTEBROPLASTY
00613994745590CEMENT, BONE, VERTEBROPLASTY
00613994745569CEMENT, BONE, VERTEBROPLASTY
00613994745552CEMENT, BONE, VERTEBROPLASTY
00613994583215CEMENT, BONE, VERTEBROPLASTY
00613994515155CEMENT, BONE, VERTEBROPLASTY
00643169097865CEMENT, BONE, VERTEBROPLASTY
00643169097834CEMENT, BONE, VERTEBROPLASTY
00643169097810CEMENT, BONE, VERTEBROPLASTY
00643169097803CEMENT, BONE, VERTEBROPLASTY
00643169097797CEMENT, BONE, VERTEBROPLASTY
00808232001372CEMENT, BONE, VERTEBROPLASTY

Maude Adverse Events

KYPHON XPEDE BONE CEMENTMEDTRONIC SOFAMOR DANEK USA, INC2020-03-29
KYPHON XPEDE BONE CEMENTMEDTRONIC SOFAMOR DANEK USA, INC2020-03-29
CONFIDENCE SPINAL CMT SYS, 11CMEDOS INTERNATIONAL SàRL CH2020-03-26
KYPHON HV-R BONE CEMENTMEDTRONIC SOFAMOR DANEK USA, INC2020-03-23
CEMENT, BONE, VERTEBROPLASTYMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-17
UNK - BIOMATERIAL - CEMENT: TRAUMACEMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-16
UNKNOWN BIOMATERIAL - CEMENTMEDOS INTERNATIONAL SàRL CH2020-03-13
UNKNOWN BIOMATERIAL - CEMENTMEDOS INTERNATIONAL SàRL CH2020-03-13
VERTECEM V+ CEMENT KITOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-12
VERTECEM V+ CEMENT KITOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-12
VERTECEM V+ CEMENT KITOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-12
VERTECEM V+ CEMENT KITOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-12
VERTECEM V+ CEMENT KITOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-12
VERTECEM V+ CEMENT KITOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-12
CONFIDENCE KIT, NO NEEDLESDEPUY SPINE INC2020-03-11
CONFIDENCE HALF DOSE KIT (5CC)DEPUY SPINE INC2020-03-09
KYPHX? HV-R? BONE CEMENTMDT KYPHON NEUCHATEL MFG2020-03-09
KYPHX HV-R BONE CEMENTMDT KYPHON NEUCHATEL MFG2020-03-05
PCD PREC SYS LONG TUBE W/VPLXSTRYKER INSTRUMENTS-KALAMAZOO2020-03-04
CONFIDENCE KIT, NO NEEDLESMEDOS INTERNATIONAL SàRL CH2020-02-28
STABILIT MX.STABILIT?.STABILIT? MX FRACTURE KITMERIT MEDICAL IRELAND LTD2020-02-27
CEMENT, BONE, VERTEBROPLASTYMEDTRONIC SOFAMOR DANEK USA, INC.2020-02-27
KYPHON HV-R BONE CEMENTMEDTRONIC SOFAMOR DANEK USA, INC2020-02-26
CONFIDENCE SPINAL CMT SYS, 11CMEDOS INTERNATIONAL SàRL CH2020-02-25
KYPHX HV-R BONE CEMENTMEDTRONIC SOFAMOR DANEK USA, INC2020-02-25
KYPHX HV-R BONE CEMENTMDT KYPHON NEUCHATEL MFG2020-02-18
UNKNOWN BIOMATERIAL - CEMENTMEDOS INTERNATIONAL SàRL CH2020-02-13
KYPHON BONE CEMENTMEDTRONIC SOFAMOR DANEK USA, INC.2020-02-07
KYPHON HV-R BONE CEMENTMEDTRONIC SOFAMOR DANEK USA, INC2020-02-07
CONFIDENCE KIT, NO NEEDLESMEDOS INTERNATIONAL SàRL CH2020-02-05
KYPHON XPEDE BONE CEMENTMEDTRONIC SOFAMOR DANEK USA, INC2020-02-05
ACTIVOS BONE CEMENTMEDTRONIC SOFAMOR DANEK USA, INC.2020-02-05
ACTIVOS BONE CEMENTMEDTRONIC SOFAMOR DANEK USA, INC.2020-02-05
CEMENT, BONE, VERTEBROPLASTYMEDTRONIC SOFAMOR DANEK USA, INC.2020-02-05
CEMENT, BONE, VERTEBROPLASTYMEDTRONIC SOFAMOR DANEK USA, INC.2020-02-05
CEMENT, BONE, VERTEBROPLASTYMEDTRONIC SOFAMOR DANEK USA, INC.2020-02-05
CEMENT, BONE, VERTEBROPLASTYMEDTRONIC SOFAMOR DANEK USA, INC.2020-02-05
CEMENT, BONE, VERTEBROPLASTYMEDTRONIC SOFAMOR DANEK USA, INC.2020-02-05
UNKNOWN BIOMATERIAL - CEMENTDEPUY SPINE INC2020-02-04
UNKNOWN BIOMATERIAL - CEMENTDEPUY SPINE INC2020-02-04
SPINEJACK EXPANSION KIT 5.8MMSTRYKER INSTRUMENTS-KALAMAZOO2020-01-28
11G/15MM IVAS SYSTEM KITSTRYKER INSTRUMENTS-PUERTO RICO2020-01-28
CONFIDENCE HYDRAULIC PUMPMEDOS INTERNATIONAL SàRL CH2020-01-24
CONFIDENCE HYDRAULIC PUMPMEDOS INTERNATIONAL SàRL CH2020-01-24
CONFIDENCE KIT, NO NEEDLESMEDOS INTERNATIONAL SàRL CH2020-01-24
CONFIDENCE HYDRAULIC PUMPMEDOS INTERNATIONAL SàRL CH2020-01-24
CONFIDENCE KIT, NO NEEDLESMEDOS INTERNATIONAL SàRL CH2020-01-24
CONFIDENCE KIT, NO NEEDLESMEDOS INTERNATIONAL SàRL CH2020-01-24
KYPHON HV-R BONE CEMENTMEDTRONIC SOFAMOR DANEK USA, INC2020-01-18
KYPHON HV-R BONE CEMENTMEDTRONIC SOFAMOR DANEK USA, INC2020-01-16
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