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510(k) K051836

SKELITE RESORBABLE CEMENT RESTRICTOR by Millenium Biologix, Inc. — Product Code JDK

K051836 is an FDA 510(k) premarket notification submitted by Millenium Biologix, Inc. for the device "SKELITE RESORBABLE CEMENT RESTRICTOR". The FDA issued a decision of SESU on November 21, 2005. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Millenium Biologix, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESU ()
Decision Date
November 21, 2005
Date Received
July 6, 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 Millenium Biologix, Inc.

  • K011726 — MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER (May 16, 2002)

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)
  • 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