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Response Spine System

by Orthopediatrics Corp.

510(k) K130655

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130655 Date8 May 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OSH
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Response Spine System is a pediatric spinal fusion system designed for the treatment of scoliosis in children. It is a comprehensive orthopedic device intended for use in spinal deformity correction procedures.

The system is supplied as a non-sterile, reusable implant system and is indicated for use in pediatric patients. It has received FDA 510(k) clearance (K130655) and is classified under product code OSH. The device is manufactured by OrthoPediatrics Corp. and is intended for use in hospital or surgical center settings by trained medical professionals.

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Questions

AI-generated answers, 28 Sep 2026

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

  • What is the Response Spine System used for?

    The Response Spine System is designed for the treatment of scoliosis in pediatric patients. It is a comprehensive orthopedic implant system intended for use in spinal deformity correction procedures to stabilize and fuse the spine in children undergoing surgical correction.

  • How is the Response Spine System supplied and is it sterile or reusable?

    The Response Spine System is supplied as a non-sterile, reusable implant system. It must be cleaned and sterilized by the healthcare facility prior to each use, as it is not provided in a sterile condition and is designed for multiple uses after proper reprocessing.

  • What regulatory clearance does the Response Spine System have?

    The Response Spine System has received FDA 510(k) clearance under submission number K130655. It was determined to be substantially equivalent to a predicate device and is classified under product code OSH for orthopedic spinal fusion systems.