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510(k) K980288

SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM by Spine-Tech, Inc. — Product Code KWP

K980288 is an FDA 510(k) premarket notification submitted by Spine-Tech, Inc. for the device "SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM". The FDA issued a decision of SN on July 29, 1998. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Spine-Tech, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
July 29, 1998
Date Received
January 26, 1998
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 Spine-Tech, Inc.

  • K970040 — SPINE-TECH BONE HARVESTER (February 28, 1997)
  • K951268 — SPINE-TECH MODIFIED LAPAROSCOPIC SPINAL FUSION INSTRUMENT SYSTEM (July 31, 1995)
  • K940913 — SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM (October 4, 1994)

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