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510(k) K071261

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

K071261 is an FDA 510(k) premarket notification submitted by Scient'X for the device "ISOBAR SEMI-RIGID DUAL DAMPENER". The FDA issued a decision of Substantially Equivalent on April 17, 2008. The device falls under product code NQP (Posterior Metal/Polymer Spinal System, Fusion), a Class II device regulated under 21 CFR 888.3070. Scient'X has at least 10 other 510(k) clearances on record.

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)

Other clearances for product code NQP

  • K203678 — CD HORIZON™ Spinal System (January 15, 2021)
  • 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)

FDA data resources