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510(k) K021879

CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) by Depuyacromed — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2002
Date Received
June 7, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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  • K030833 — DEPUY ACROMED VBR SYSTEM (April 10, 2003)
  • K030383 — MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS (February 26, 2003)
  • K030249 — SURGICAL TITANIUM MESH SYSTEM (February 14, 2003)
  • K030103 — SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS (February 5, 2003)
  • K023835 — DEVEX MESH SYSTEM (January 29, 2003)
  • K024348 — MONARCH SPINE SYSTEM (January 28, 2003)
  • K023804 — MOSS MIAMI SPINAL SYSTEM PIN NUT (January 23, 2003)
  • K021039 — BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM (December 11, 2002)

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  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
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  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K143013 — Spinal Inner Fixation System (December 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)