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510(k) K151362

HC Spinal System by Hung Chun Bio-S Co., Ltd. — Product Code MNH

K151362 is an FDA 510(k) premarket notification submitted by Hung Chun Bio-S Co., Ltd. for the device "HC Spinal System". The FDA issued a decision of Substantially Equivalent on May 5, 2016. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Hung Chun Bio-S Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2016
Date Received
May 21, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Other clearances by Hung Chun Bio-S Co., Ltd.

  • K172821 — Ti-one 101 TS Dental Implant System (June 11, 2018)
  • K110425 — HC-BIOS DENTAL IMPLANT (July 27, 2012)

Other clearances for product code MNH

  • K162066 — Reliance Spinal Screw System (December 2, 2016)
  • K162801 — CastleLoc Spinal Fixation System (November 3, 2016)
  • K162143 — FixxSure® X-Link (September 23, 2016)
  • K161151 — Spinal fixation system (September 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K143013 — Spinal Inner Fixation System (December 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)
  • K151116 — CapLOX II/TowerLOX Pedicle Screw System (June 26, 2015)

FDA data resources