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510(k) K052367

SCIENT'X CEMENT RESTRICTOR by Scient'X — Product Code JDK

K052367 is an FDA 510(k) premarket notification submitted by Scient'X for the device "SCIENT'X CEMENT RESTRICTOR". The FDA issued a decision of SESU on October 5, 2005. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Scient'X has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
October 5, 2005
Date Received
August 29, 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 Scient'X

  • K071261 — ISOBAR SEMI-RIGID DUAL DAMPENER (April 17, 2008)
  • K062912 — SCIENT'X SPINAL SYSTEM (February 5, 2007)
  • K052763 — STELLA CERVICAL PLATE (November 10, 2005)
  • K050348 — CO VERTEBRAL BODY REPLACEMENT (May 27, 2005)
  • K051063 — POLYAXIAL HEMISPHERICAL SPINAL SCREWS (May 23, 2005)
  • K043001 — MX POLYAXIAL PEDICLE SCREW (December 1, 2004)
  • K042964 — MX MONOAXIAL PEDICLE SCREW (November 22, 2004)
  • K042317 — CERVICAL PLATE (September 24, 2004)
  • K040747 — ALADYN RIGID SPINE PLATE (June 17, 2004)
  • K040454 — BIOFILL BONE VOID FILLER (May 7, 2004)

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)
  • 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