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510(k) K030871

FIDJI LARGE CEMENT RESTRICTOR by Spine Next SA — Product Code JDK

K030871 is an FDA 510(k) premarket notification submitted by Spine Next SA for the device "FIDJI LARGE CEMENT RESTRICTOR". The FDA issued a decision of SESU on December 22, 2003. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Spine Next SA has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
December 22, 2003
Date Received
March 19, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Cement Restrictor
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

Other clearances by Spine Next SA

  • K030767 — FIDJI SMALL CEMENT RESTRICTOR (December 22, 2003)
  • K031265 — SHIRAZ-JAVA SPINAL FIXATION SYSTEM (October 9, 2003)

Other clearances for product code JDK

  • K210062 — Mectaplug PE II (April 8, 2021)
  • K061465 — KMI CEMENT RESTRICTOR IMPLANT (October 5, 2006)
  • K061698 — MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR (July 12, 2006)
  • K060247 — LIFE SPINE CEMENT RESTRICTOR (May 11, 2006)
  • K060132 — SPINAL USA CEMENT RESTRICTOR SYSTEM (March 16, 2006)
  • K051371 — INTERBODY INNOVATIONS CEMENT RESTRICTOR (December 6, 2005)
  • K051836 — SKELITE RESORBABLE CEMENT RESTRICTOR (November 21, 2005)
  • K051607 — NOVASPINE CEMENT RESTRICTOR NSCR (October 7, 2005)
  • K052367 — SCIENT'X CEMENT RESTRICTOR (October 5, 2005)
  • K041382 — POLYGRAFT BGS; BONE GRAFT SUBSTITUTE (June 17, 2005)

FDA data resources