Home / 510(k) Clearances / K010911

510(k) K010911

MACROPORE OS SPINAL SYSTEM by Macropore Biosurgery, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2001
Date Received
March 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Macropore Biosurgery, Inc.

  • K042261 — MACROPORE PURICEL LIPOPLASTY SYSTEM (September 20, 2004)
  • K041105 — MACROPORE HYDROSORB SPINE SYSTEM (July 28, 2004)
  • K031955 — MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET (September 22, 2003)
  • K031785 — MACROPORE CARDIO-WRAP (TS) (September 4, 2003)
  • K024169 — MACROPORE OS RECONSTRUCTION (July 1, 2003)
  • K023643 — MACROPORE SURGICAL BARRIER FILM (February 21, 2003)
  • K021164 — MACROPORE OS TRAUMA (July 1, 2002)
  • K012025 — MACROPORE SURGIWRAP (TS) (December 3, 2001)
  • K012769 — MACROPORE ENT RECONSTRUCTION FILM (October 25, 2001)
  • K012413 — MACROPORE FX, PS, NS, LP (September 18, 2001)

Other clearances for product code KWQ

  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K250446 — Frida™ Anterior Cervical Plate System (May 23, 2025)
  • K250602 — X-PAC® N-GAGE™ Lumbar Plate System (May 20, 2025)
  • K250486 — Skyway Anterior Cervical Plate System (April 10, 2025)