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) |
|---|---|---|---|
| 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 |
| Mar 25, 2021 | Zavation 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures. Terminated |
NDN | None listed |
| Mar 25, 2021 | Zavation 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. 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), CODE INTVM-DSSKbd. 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 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 Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| 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 | K141419 |
| Mar 25, 2021 | Zavation ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures. Terminated |
NDN | K141419 |
| Mar 25, 2021 | Zavation 10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. 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), INTVM-DSSKBD. For use in Orthopedic / spinal procedures. Terminated |
NDN | K130616 K141419 |
| Apr 1, 2020 | Howmedica Osteonics Corp. Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010 Terminated |
NDN | K080108 |
| Dec 15, 2017 | DePuy Spine, Inc. Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630)
The CONFIDENCE SPINAL CEMENT SYSTEM 11cc Kit is intended for per Terminated |
NDN | K060300 |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830
for spinal orthopedic use. Terminated |
NDN | K123942 |
| Aug 15, 2016 | Stryker Instruments Div. of Stryker Corporation Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement.
Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, Terminated |
NDN | K150582 |
| Sep 3, 2013 | DePuy Spine, Inc. CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000
The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation Terminated |
NDN | K060300 |
| Sep 3, 2013 | DePuy Spine, Inc. CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000
The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for Terminated |
NDN | K060300 |
| Sep 3, 2013 | DePuy Spine, Inc. CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000
The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixati Terminated |
NDN | K060300 |
| Mar 18, 2013 | DePuy Spine, Inc. DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT
Catalog Number: 283913000.
Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Terminated |
NDN | K060300 |
| Mar 18, 2013 | DePuy Spine, Inc. DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT
Catalog Number: 283910000.
Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Terminated |
NDN | K060300 |
| Mar 18, 2013 | DePuy Spine, Inc. DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT
Catalog Number: 283907000.
Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Terminated |
NDN | K060300 |
| Mar 18, 2013 | DePuy Spine, Inc. DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT
Catalog Number:283905000.
Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Terminated |
NDN | K060300 |
| Mar 11, 2011 | Medtronic Spine LLC, formerly Kyphon Inc Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Numbe Terminated |
NDN | K033801 K041584 |
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