Panels › Orthopedic › Product code NDN · Class 2
Cement, Bone, Vertebroplasty
Regulation 888.3027
1510(k)s in 12 months (108 all time)
0recalls in 12 months (86 all time)
51recalls that name a 510(k)
Top companies in NDN
| Company | 510(k)s | Recalls |
|---|---|---|
| Zavation, LLC | 1 | 71 |
| Depuy Spine, Inc. | 2 | 8 |
| Stryker Corp. | 7 | 0 |
| Teknimed Sas | 6 | 1 |
| Arthrocare Corp. | 6 | 0 |
| Medtronic | 5 | 0 |
| Tecres S.P.A. | 5 | 0 |
| Dfine, Inc. | 4 | 0 |
| Disc-O-Tech Medical Technologies, Ltd. | 4 | 0 |
| Medtronic Sofamor Danek | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2023 | TEKNIMED SAS HIGH V+ Spinal Cement System REF T040321K Open, Classified |
NDN | K161114 |
| May 18, 2021 | Stryker Spine Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979 Terminated |
NDN | K080108 |
| May 18, 2021 | Stryker Spine Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962 Terminated |
NDN | K080108 |
| Mar 25, 2021 | Zavation VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty System, 15mm, Part Numbers:
a) VCF-1015-2
b) VCF-1015-2A. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation OsteoFlex BONE CEMENT, REF Numbers:
a) INTV-OSFL
b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation InterV 11G Kyphoplasty Kit, REF Numbers:
a) INTVMN-10-DSK
b) INTVMN-15-DSK
c) INTVMN-15-DSKC
d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation InterV CurvePlus Kit, REF Numbers:
a) INTVMC-15-FLDSK
b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation InterV, 10G FLEX Kyphoplasty, REF Number:
a) INTVM-15-FLDSK
b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation InterV, 10G Kyphoplasty Kits, REF numbers:
a) INTVM-10-DSK
b) INTVM-10-SBK
c) INTVM-15-DSK
d) INTVM-15-DSKC
e) INTVM-15-SBK
f) INTVM-15-SIKBC
g) INTVM-20-DSK
h) INTVM-20-SBK. For use in Orthopedic / Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
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