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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

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)

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  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
  • K142741 — OASYS System (January 15, 2015)
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