Home / 510(k) Clearances / K050706

510(k) K050706

HARMONY PORT SYSTEM, MODEL 1907 SERIES by Spinal Concepts, Inc. — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2005
Date Received
March 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining, For Neurosurgery
Device Class
Class II
Regulation Number
882.4800
Review Panel
NE
Submission Type

Other clearances by Spinal Concepts, Inc.

  • K051000 — FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE (May 19, 2005)
  • K040096 — SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM (July 1, 2004)
  • K033663 — SPINAL CONCEPTS INC. CODA (May 27, 2004)
  • K033517 — SPINAL CONCEPTS INC. CADENCE AND TRAXIS (February 18, 2004)
  • K031855 — SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM (September 17, 2003)
  • K031985 — SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM (September 11, 2003)
  • K031318 — TRAXIS CEMENT RESTRICTOR (August 22, 2003)
  • K031672 — SPINAL CONCEPTS, INC. INFIX SYSTEM (August 7, 2003)
  • K031837 — MODIFICATION TO FORTITUDE CEMENT RESTRICTOR (July 24, 2003)
  • K030087 — SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM (July 17, 2003)

Other clearances for product code GZT

  • K210615 — Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clam (May 13, 2022)
  • K202694 — Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (January 14, 2021)
  • K202072 — MindsEye Expandable Port (August 26, 2020)
  • K180610 — Geister retractor for neuro - and spine surgery (August 29, 2018)
  • K172433 — NICO BrainPath (September 7, 2017)
  • K161680 — MEDICON Spinal Spreading Systems (March 24, 2017)
  • K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological (March 20, 2017)
  • K161004 — Self-retaining Retractor (September 9, 2016)
  • K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (June 12, 2015)
  • K120691 — BRAIN PORT (June 5, 2012)