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ULC Spinal Pedicle Screw System

by Otis Biotech Co., Ltd. 510(k)

Active United States

510(k) K083077

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083077 Date26 Oct 2009ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MNH
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ULC Spinal Pedicle Screw System is a spinal fixation device classified as a pedicle screw system under product code MNH. It is designed for posterior and non-cervical pedicle fixation, providing stability to the lumbar and sacral spine (L3 to sacrum) during surgical fusion procedures.

This system is intended for use in skeletally mature patients undergoing fusion with autogenous bone graft, specifically for severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra. Supplied as a sterile, single-use device, it includes pedicle screws and transverse connector bars to secure spinal alignment. Authorized under FDA 510(k) clearance (K083077), it adheres to orthopedic surgical standards for spinal stabilization.

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