510(k) K141419 ยท NDN Cement, Bone, Vertebroplasty
ZVPLASTY
| Applicant | Zavation, LLC, Flowood MS, US |
| Decision | Substantially Equivalent, Sep 12, 2014 |
| Received | May 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141419
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2021 | Zavation 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. 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 | None listed |
| Mar 25, 2021 | Zavation ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. 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 | None listed |
| Mar 25, 2021 | Zavation ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. 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 | None listed |
| Mar 25, 2021 | Zavation ZVplasty Cement Delivery Cannula, REF VCF-1007. 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 | None listed |
| Mar 25, 2021 | Zavation 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10G DIRECT DOUBLE BONE ACCESS KIT. 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 | None listed |
| Mar 25, 2021 | Zavation 10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10G CEMENT DELIVERY CANNULA. 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.