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510(k) K072321

BIOFLEX by Biospine Co., Ltd. — Product Code NQP

K072321 is an FDA 510(k) premarket notification submitted by Biospine Co., Ltd. for the device "BIOFLEX". The FDA issued a decision of Substantially Equivalent on March 25, 2008. The device falls under product code NQP (Posterior Metal/Polymer Spinal System, Fusion), a Class II device regulated under 21 CFR 888.3070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2008
Date Received
August 20, 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.

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  • 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