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510(k) K041449

SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT by Interpore Cross Intl. — Product Code KWP

K041449 is an FDA 510(k) premarket notification submitted by Interpore Cross Intl. for the device "SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT". The FDA issued a decision of Substantially Equivalent on July 1, 2004. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Interpore Cross Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2004
Date Received
June 1, 2004
Clearance Type
Special
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 Interpore Cross Intl.

  • K050861 — PEEK CAS (May 27, 2005)
  • K031399 — INTERGRO DBM (February 18, 2005)
  • K041407 — TITANIUM MESH IMPLANT (December 29, 2004)
  • K043229 — MODIFICATION TO ALTIUS OCT SYSTEM (December 21, 2004)
  • K042798 — C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM (November 4, 2004)
  • K040928 — EXPANDABLE PEEK VBR IMPLANT (August 27, 2004)
  • K041794 — C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM (July 19, 2004)
  • K033961 — ALTIUS OCT SYSTEM (April 14, 2004)
  • K040168 — MODIFICATION TO GEO STRUCTURE (April 8, 2004)
  • K031772 — TI FENESTRATED PLATE (September 5, 2003)

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