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510(k) K161151

Spinal fixation system by Canwell Medical Co., Ltd. — Product Code MNH

K161151 is an FDA 510(k) premarket notification submitted by Canwell Medical Co., Ltd. for the device "Spinal fixation system". The FDA issued a decision of Substantially Equivalent on September 21, 2016. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Canwell Medical Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2016
Date Received
April 25, 2016
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 Canwell Medical Co., Ltd.

  • K242973 — CanMINI Hand and Foot System (April 24, 2025)
  • K142943 — Metallic Locking Bone Plate and Screw (August 3, 2015)

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)
  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
  • K151362 — HC Spinal System (May 5, 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