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510(k) K100089

SYNTHES T-PAL SPACER by Synthes Spine — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2010
Date Received
January 12, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Synthes Spine

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  • K111048 — SYNTHES SCOUT TACK FIXATION (June 14, 2012)
  • K120928 — SYNTHES MATRIX SYSTEM (May 18, 2012)
  • K120571 — SYNTHES USS CONNECTOR (May 14, 2012)
  • K113149 — SYNTHES USS CONNECTORS (February 1, 2012)
  • K113044 — SYNTHES MIRS (December 21, 2011)
  • K111358 — SYNTHES USS (November 18, 2011)
  • K103558 — SYNTHES SCOUT VESSEL GUARD (February 18, 2011)
  • K103287 — SYNTHES 6.0 COCR AND CPT TI-3 RODS (January 5, 2011)

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