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510(k) K122175

MENDEC SPINE HV, MENDEC SPINE HV SYSTEM by Tecres S.P.A. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2013
Date Received
July 23, 2012
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 Tecres S.P.A.

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  • K181732 — InterSpace Knee Extra-Large Size, InterSpace Knee ATS (April 27, 2019)
  • K112983 — SPACER-S (December 12, 2011)
  • K101356 — Spacer-G and Spacer-K (September 20, 2011)
  • K092773 — CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST (November 24, 2009)
  • K062273 — SPACER-G TEMPORARY HIP PROSTHESIS (May 22, 2008)
  • K062274 — SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221 (May 22, 2008)
  • K063438 — VSPSPN (January 17, 2007)

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  • 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)