Zvplasty
FDA 510(k) K141419 · Zavation, LLC
510(k) numberK141419
Submission
- Device name
- Zvplasty
- Applicant
- Zavation, LLC
Flowood, MS, US - Received
- May 29, 2014
- Decision date
- September 12, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
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| K162206 | Zavation IBFMAX · Traditional | 04/04/2017SE |
| K162575 | Z-LINKPC SystemNKG · Traditional | 03/03/2017SE |
| K162824 | Z-Span Plate SystemKWQ · Traditional | 02/17/2017SE |
| K161016 | Z-Clamp ISP SystemPEK · Traditional | 10/19/2016SE |
| K153404 | Zavation Spinal SystemMNH · Traditional | 04/21/2016SE |
| K160362 | Z-Span Plate SystemKWQ · Traditional | 03/22/2016SE |
| K142392 | Zavation Posterior LEIFMAX · Traditional | 04/29/2015SE |
| K142271 | Zavation Z-Link LumbarOVD · Traditional | 12/19/2014SE |
| K141005 | Z-Link CervicalOVE · Traditional | 08/07/2014SE |
| K130030 | Zavation Cervical Plate SystemKWQ · Traditional | 04/25/2013SE |
Questions and answers
When was Zvplasty cleared by the FDA?
Zvplasty (K141419) received a 510(k) decision of Substantially Equivalent on September 12, 2014, 106 days after the submission was received.
What is the product code of K141419?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.