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510(k) K083077

ULC SPINAL PEDICLE SCREW SYSTEM by Otis Biotech Co., Ltd. — Product Code MNH

K083077 is an FDA 510(k) premarket notification submitted by Otis Biotech Co., Ltd. for the device "ULC SPINAL PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 26, 2009. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Otis Biotech Co., Ltd. has 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 26, 2009
Date Received
Oct 16, 2008
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
510(k)

Other clearances by Otis Biotech Co., Ltd.

  • K170534 — PROLIXUS TOTAL KNEE SYSTEM (Nov 9, 2017)
  • K101472 — MULTIFIT TOTAL HIP SYSTEM (Jan 5, 2011)

Other clearances for product code MNH

  • K162066 — Reliance Spinal Screw System (Dec 2, 2016)
  • K162801 — CastleLoc Spinal Fixation System (Nov 3, 2016)
  • K162143 — FixxSure® X-Link (Sep 23, 2016)
  • K161151 — Spinal fixation system (Sep 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (Aug 30, 2016)
  • K151362 — HC Spinal System (May 5, 2016)
  • K153404 — Zavation Spinal System (Apr 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (Mar 2, 2016)
  • K143013 — Spinal Inner Fixation System (Dec 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (Sep 10, 2015)

FDA data resources