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510(k) K051607

NOVASPINE CEMENT RESTRICTOR NSCR by Novaspine, LLC — Product Code JDK

K051607 is an FDA 510(k) premarket notification submitted by Novaspine, LLC for the device "NOVASPINE CEMENT RESTRICTOR NSCR". The FDA issued a decision of Substantially Equivalent on October 7, 2005. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Novaspine, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2005
Date Received
June 17, 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 Novaspine, LLC

  • K062456 — NOVASPINE POWERED SUCTION PUMP PRO-1 (October 16, 2006)
  • K061133 — SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S (July 11, 2006)

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)
  • 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