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510(k) K870830

WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM by Warsaw Orthopedic, Inc. — Product Code KWP

K870830 is an FDA 510(k) premarket notification submitted by Warsaw Orthopedic, Inc. for the device "WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM". The FDA issued a decision of Substantially Equivalent on May 4, 1987. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Warsaw Orthopedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1987
Date Received
March 3, 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 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)
  • K880212 — TSRH H/M HOOK HOLDER W/ROD MOVER (March 4, 1988)
  • K880211 — TSRH H/M HOOK HOLDER (March 4, 1988)
  • K880215 — TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD (February 18, 1988)
  • K880214 — TSRH H/M TORQUE LIMITING WRENCH (February 18, 1988)
  • K870843 — SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (May 27, 1987)
  • K870842 — SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP (May 27, 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)
  • 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