Home / 510(k) Clearances / K130146

510(k) K130146

SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM by Synthes (Usa), LLC — Product Code NDN

K130146 is an FDA 510(k) premarket notification submitted by Synthes (Usa), LLC for the device "SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM". The FDA issued a decision of Substantially Equivalent on May 20, 2013. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Synthes (Usa), LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2013
Date Received
January 22, 2013
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 Synthes (Usa), LLC

  • K180821 — TruMatch Graft Cage - Long Bone (December 21, 2018)
  • K152239 — Zero-P Natural Plate System (December 2, 2015)
  • K131984 — SYNTHES SYNSONIC ULNA NAIL (March 31, 2014)
  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)
  • K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (August 8, 2011)
  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (July 28, 2011)
  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)
  • K102656 — SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM (December 20, 2010)

Other clearances for product code NDN

  • K251896 — XeliteMed SuperM-Fix Spinal Bone Cement (January 28, 2026)
  • K250637 — VCFix Spinal System (May 30, 2025)
  • 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)
  • K231340 — Renova Spine Balloon Catheter (October 30, 2023)
  • 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)

FDA data resources