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510(k) K040276

QUANTUM CEMENT RESTRICTOR by Quantum Orthopedics — Product Code JDK

K040276 is an FDA 510(k) premarket notification submitted by Quantum Orthopedics for the device "QUANTUM CEMENT RESTRICTOR". The FDA issued a decision of Substantially Equivalent on April 30, 2004. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Quantum Orthopedics has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2004
Date Received
February 5, 2004
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 Quantum Orthopedics

  • K062004 — MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT (August 15, 2006)
  • K061576 — MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM (July 3, 2006)
  • K052641 — MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT (April 12, 2006)
  • K060491 — QUANTUM ANTERIOR CERVICAL PLATE SYSTEM (March 13, 2006)
  • K050449 — QUANTUM VERTEBRAL BODY REPLACEMENT (July 7, 2005)

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