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510(k) K043522

ISSYS PEDICLE SCREW SYSTEM by Custom Spine, Inc. — Product Code KWP

K043522 is an FDA 510(k) premarket notification submitted by Custom Spine, Inc. for the device "ISSYS PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on January 14, 2005. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Custom Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2005
Date Received
December 20, 2004
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 Custom Spine, Inc.

  • K143143 — PATHWAY ELIF (July 22, 2015)
  • K132596 — PROPOSED OPTIMUS (April 11, 2014)
  • K120597 — KOMPREDA (May 3, 2013)
  • K111726 — PATHWAY AVID (February 6, 2012)
  • K111774 — PATHWAY MODEL 07XXXX (July 20, 2011)
  • K111099 — ISSYS LP SPINAL FIXATION SYSTEM (May 5, 2011)
  • K101151 — REGENT ANTERIOR CERVICAL PLATE (May 19, 2010)
  • K092904 — PATHWAY IVB/VBR (December 22, 2009)
  • K091134 — CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE (August 17, 2009)
  • K090566 — PATHWAY AVID (June 1, 2009)

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)

FDA data resources