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510(k) K103091

LANX SPINAL FIXATION SYSTEM by Lanx, Inc. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2011
Date Received
October 19, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

Other clearances by Lanx, Inc.

  • K131547 — LANX FUSION SYSTEM (July 12, 2013)
  • K131156 — LANX SPINAL FIXATION SYSTEM (May 24, 2013)
  • K123767 — LANX FUSION SYSTEM- SA (March 18, 2013)
  • K121316 — LANX SPINAL FIZATION SYSTEM (September 10, 2012)
  • K122145 — LANX SPINAL FIXATION SYSTEM (August 17, 2012)
  • K121940 — LANX SPINAL FIXATION SYSTEM (August 2, 2012)
  • K120399 — LANX SPINAL FIXATION SYSTEM (March 9, 2012)
  • K113434 — LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) (December 19, 2011)
  • K112388 — LANX CERVICAL SA (December 16, 2011)
  • K103237 — LANX SPINAL SYSTEM (March 25, 2011)

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  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
  • K142741 — OASYS System (January 15, 2015)
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