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510(k) K870830

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

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)
  • K880211 — TSRH H/M HOOK HOLDER (March 4, 1988)
  • K880212 — TSRH H/M HOOK HOLDER W/ROD MOVER (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)
  • K870842 — SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP (May 27, 1987)
  • K870843 — SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (May 27, 1987)
  • K870848 — SCHULTZ METACARPAL COMPONENT DRIVER (March 13, 1987)

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  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
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