510(k) K071261

ISOBAR SEMI-RIGID DUAL DAMPENER by Scient'X — Product Code NQP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 17, 2008
Date Received: May 4, 2007
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Posterior Metal/Polymer Spinal System, Fusion
Device Class: Class II
Regulation Number: 888.3070
Review Panel: OR
Submission Type

This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

Other clearances by Scient'X

K062912 — SCIENT'X SPINAL SYSTEM (February 5, 2007)
K052763 — STELLA CERVICAL PLATE (November 10, 2005)
K052367 — SCIENT'X CEMENT RESTRICTOR (October 5, 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)

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K191066 — CD Horizon Astute Spinal System (October 3, 2019)
K182928 — CD Horizon Spinal System (January 11, 2019)
K133164 — DYNESYS TOP-LOADING SPINAL SYSTEM (January 16, 2014)
K101704 — ZIMMER DTO PIN PRESS INSTRUMENT (August 18, 2010)
K101083 — DSS STABILIZATION SYSTEM (July 2, 2010)
K092234 — DYNESYS TOP-LOADING SPINAL SYSTEM (October 1, 2009)
K091944 — MODIFICATION TO: DSS STABILIZATION SYSTEM (August 3, 2009)
K073439 — TRANSITION STABILIZATION SYSTEM (February 20, 2009)
K080241 — DDS STABILIZATION SYSTEM (November 28, 2008)