Ebi Vertebroplasty Systems
FDA 510(k) K060148 · Ebi, L.P.
510(k) numberK060148
Submission
- Device name
- Ebi Vertebroplasty Systems
- Applicant
- Ebi, L.P.
Parsippany, NJ, US - Received
- January 19, 2006
- Decision date
- March 13, 2006
- 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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More from Tecres S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K100438 | Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemNKB · Special | 06/23/2010SE |
| K100220 | Polaris Spinal SystemNKB · Special | 05/17/2010SE |
| K093880 | Peanut Growth Control Plating SystemHRS · Traditional | 04/16/2010SE |
| K092574 | Esl Spinal SystemMAX · Traditional | 02/04/2010SE |
| K093057 | Biomet Vision Footring SystemKTT · Traditional | 12/01/2009SE |
| K092336 | C-Thru Spinal SystemMQP · Traditional | 10/15/2009SE |
| K091381 | Ibex Spinal SystemMAX · Traditional | 08/07/2009SE |
| K090203 | 5.5 Helical Flange Spinal System, Polaris ComponentsNKB · Special | 07/30/2009SE |
| K090523 | Polaris Spinal SystemNKB · Traditional | 07/01/2009SE |
| K082406 | Expandable Peek-Optima ImplantMAX · Traditional | 01/14/2009SE |
Questions and answers
When was Ebi Vertebroplasty Systems cleared by the FDA?
Ebi Vertebroplasty Systems (K060148) received a 510(k) decision of Substantially Equivalent on March 13, 2006, 53 days after the submission was received.
What is the product code of K060148?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.