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510(k) K870085

ANTERIOR SPINAL FIXATION PLATE by Terray Manufacturing, Inc. — Product Code KWP

K870085 is an FDA 510(k) premarket notification submitted by Terray Manufacturing, Inc. for the device "ANTERIOR SPINAL FIXATION PLATE". The FDA issued a decision of Substantially Equivalent on June 30, 1987. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Terray Manufacturing, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1987
Date Received
January 8, 1987
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 Terray Manufacturing, Inc.

  • K910874 — THORACIC ANTERIOR SPINAL FIXATION PLATE (February 3, 1992)
  • K882934 — CASF CANCELLOUS BONE SCREW, BT650 (October 13, 1988)
  • K882871 — CASF DRILL GUIDE DG 170 (September 23, 1988)
  • K883193 — CASF STERILIZATION TRAY (August 10, 1988)
  • K883125 — CASF STERILIZATION TRAY (August 10, 1988)
  • K870082 — BONE PLATE (May 6, 1987)
  • K870083 — FERRAY EXTRACTOR (February 26, 1987)
  • K870084 — RD 140 SURGICAL BENDER (January 28, 1987)

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