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510(k) K080526

SIERRA SYSTEM by Seaspine, Inc. — Product Code KWP

K080526 is an FDA 510(k) premarket notification submitted by Seaspine, Inc. for the device "SIERRA SYSTEM". The FDA issued a decision of Substantially Equivalent on April 16, 2008. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Seaspine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2008
Date Received
February 26, 2008
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 Seaspine, Inc.

  • K231654 — NorthStar OCT System (August 3, 2023)
  • K150469 — Integra Laminoplasty System (March 23, 2015)
  • K142488 — SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, C (December 18, 2014)
  • K133418 — INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM (May 1, 2014)
  • K132859 — INTEGRA FACET FIXATION SYSTEM (November 18, 2013)
  • K121924 — INTEGRA INTERSPINOUS PROCESS SYSTEM (September 4, 2013)
  • K130830 — INTEGRA LAMINOPLASTY SYSTEM (May 9, 2013)
  • K122571 — MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM (December 12, 2012)
  • K112206 — CARDIFF ANTERIOR CERVICAL PLATE SYSTEM (January 25, 2012)
  • K111671 — SEASPINE MONOPOLAR PROBE SYSYEM (December 28, 2011)

Other clearances for product code KWP

  • K143278 — LnK Posterior Cervical Fixation System (July 29, 2015)
  • K150753 — OASYS System (June 9, 2015)
  • K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System (June 4, 2015)
  • K142867 — Reliance Posterior Cervical-Thoracic System (April 29, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (April 28, 2015)
  • K142253 — SOLSTICE OCT System (April 23, 2015)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K142741 — OASYS System (January 15, 2015)
  • K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System (December 22, 2014)

FDA data resources