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510(k) K051371

INTERBODY INNOVATIONS CEMENT RESTRICTOR by Interbody Innovations, Llp — Product Code JDK

K051371 is an FDA 510(k) premarket notification submitted by Interbody Innovations, Llp for the device "INTERBODY INNOVATIONS CEMENT RESTRICTOR". The FDA issued a decision of SESU on December 6, 2005. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Interbody Innovations, Llp has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
December 6, 2005
Date Received
May 26, 2005
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 Interbody Innovations, Llp

  • K081614 — ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGE (September 5, 2008)
  • K073105 — PEEK SPINAL SPHERES (January 3, 2008)
  • K062992 — SPINAL SPHERES (July 27, 2007)

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)
  • 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)
  • K050699 — MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 (April 15, 2005)

FDA data resources