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Response BandLoc Spinal Fixation

by Orthopediatrics Corp. 2 variants

510(k) K161267

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161267 Date11 Aug 2016ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-2321-2017 FDA Class II initiated 24 Apr 2017

    Over-tensioning of the band resulting in damage to the band causing it to rupture

Timeline

2 dated events

  1. Cleared FDA 510(k) K161267
  2. Recall initiated FDA recalls Z-2321-2017

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  • Withdrawn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
OWI
Device class
Class II
Regulation
21 CFR Part 888.3010
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 25 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 BandLoc Spinal Fixation is a sub-laminar polyester band system that provides fixation options where anatomy and bone quality preclude pedicle screws. It is a temporary implant intended to provide stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The system may also be used in conjunction with other medical implants made of titanium alloy or CoCr alloy whenever 'wiring' may help secure the attachment of other implants.

The Response BandLoc Spinal Fixation is supplied as a system comprising a woven band, band clip, metal insert, and tulip. It is a Class II device cleared by the FDA under 510(k) K161267 for use in orthopedic surgery. The device is intended for temporary stabilization and should not remain in the body permanently. No specific information regarding sterility, single-use status, MRI safety, or storage conditions is provided in the available data.

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