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510(k) K843445

SACRAL BAR by Stuart — Product Code KWP

K843445 is an FDA 510(k) premarket notification submitted by Stuart for the device "SACRAL BAR". The FDA issued a decision of Substantially Equivalent on February 13, 1985. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Stuart has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1985
Date Received
September 5, 1984
Clearance Type
Traditional
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 Stuart

  • K897141 — SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO (June 21, 1990)
  • K890601 — STUART TITANIUM SURGICAL MESH (March 16, 1989)
  • K851414 — SEGMENTAL SPINAL RODS (June 28, 1985)
  • K820034 — ANTERIOR DISTRACTION SYSTEM (March 11, 1982)

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)
  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K143249 — 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