Home / 510(k) Clearances / K880215

510(k) K880215

TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD by Warsaw Orthopedic, Inc. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1988
Date Received
January 19, 1988
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 Warsaw Orthopedic, Inc.

  • K892877 — CRADLE, HOSPITAL BED CLOTHING (June 15, 1989)
  • K883783 — TSRH SACRAL SPINAL SCREW (April 6, 1989)
  • K883784 — TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE (April 6, 1989)
  • K880211 — TSRH H/M HOOK HOLDER (March 4, 1988)
  • K880212 — TSRH H/M HOOK HOLDER W/ROD MOVER (March 4, 1988)
  • K880214 — TSRH H/M TORQUE LIMITING WRENCH (February 18, 1988)
  • K870842 — SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP (May 27, 1987)
  • K870843 — SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (May 27, 1987)
  • K870830 — WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM (May 4, 1987)
  • K870847 — SCHULTZ PHALANGEAL COMPONENT DRIVER (March 13, 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)
  • 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)