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510(k) K820660

A HOOK DRIVER by Twin City Surgical, Inc. — Product Code KWP

K820660 is an FDA 510(k) premarket notification submitted by Twin City Surgical, Inc. for the device "A HOOK DRIVER". The FDA issued a decision of Substantially Equivalent on March 19, 1982. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Twin City Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1982
Date Received
March 10, 1982
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 Twin City Surgical, Inc.

  • K870767 — THE (CROM) TESTER (March 17, 1987)
  • K861632 — SIMS CHAIR (May 27, 1986)
  • K830585 — ANVIL RETRACTOR (May 27, 1983)
  • K820659 — A CALIPER (March 19, 1982)
  • K813067 — SPINAL WRENCH (November 24, 1981)

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