Company ยท US
Zavation
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2017. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
71recalls (0 in 12 months)
36recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | 72 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 |
| NKG | Posterior Cervical Screw System | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
| PEK | Spinous Process Plate | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 2017 | K162206 | Zavation IBF Zavation, LLC | MAX |
| Mar 3, 2017 | K162575 | Z-LINKPC System Zavation, LLC | NKG |
| Feb 17, 2017 | K162824 | Z-Span Plate System Zavation, LLC | KWQ |
| Oct 19, 2016 | K161016 | Z-Clamp ISP System Zavation, LLC | PEK |
| Apr 21, 2016 | K153404 | Zavation Spinal System Zavation, LLC | MNH |
| Mar 22, 2016 | K160362 | Z-Span Plate System Zavation, LLC | KWQ |
| Apr 29, 2015 | K142392 | Zavation Posterior LEIF Zavation, LLC | MAX |
| Dec 19, 2014 | K142271 | Zavation Z-Link Lumbar Zavation, LLC | OVD |
| Sep 12, 2014 | K141419 | ZVPLASTY Zavation, LLC | NDN |
| Aug 7, 2014 | K141005 | Z-LINK CERVICAL Zavation, LLC | OVE |
| Apr 25, 2013 | K130030 | ZAVATION CERVICAL PLATE SYSTEM Zavation, LLC | KWQ |
| Mar 28, 2012 | K120576 | ZAVATION IBF SYSTEM Zavation, LLC | MAX |
| Dec 23, 2011 | K112664 | ZAVATION IBF SYSTEMS Zavation, LLC | ODP |
| Dec 8, 2011 | K112533 | ZAVATION CERVICAL PLATE SYSTEM Zavation, LLC | KWQ |
| Nov 22, 2011 | K112484 | ZAVATION SPINAL SYSTEM Zavation, LLC | MNI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Mar 25, 2021 | Zavation ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
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