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510(k) K231340

Renova Spine Balloon Catheter by Biopsybell S.R.L. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2023
Date Received
May 9, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

Other clearances by Biopsybell S.R.L.

  • K203397 — Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10 (January 11, 2021)
  • K180315 — DISKOM (March 26, 2018)
  • K130616 — MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOP (February 7, 2014)
  • K010735 — SPEEDYBELL (August 17, 2001)
  • K011075 — EASYBELL (June 27, 2001)
  • K011104 — OSTEOBELL (May 31, 2001)

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  • K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (April 11, 2025)
  • K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement (September 18, 2024)
  • K232842 — Balloon Inflation System (February 29, 2024)
  • K240084 — V-STRUT® Vertebral Implant (February 9, 2024)
  • K221697 — INJECTION PIN (KIP(02031-02061) (03031-03061)) (March 3, 2023)
  • K223294 — SpineJack® Expansion Kit (December 20, 2022)
  • K220131 — KYPHON VuE Bone Cement (April 18, 2022)
  • K211797 — TRACKER Plus Kyphoplasty System (October 28, 2021)