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FDA 510(k)

Response BandLoc Spinal Fixation

K-Number: K200097 · 2020-03-16

ApplicantOrthoPediatrics Corp.
Decision Date2020-03-16
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Response BandLoc Spinal Fixation is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2020-03-16 under approval number K200097. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Response BandLoc Spinal Fixation?

Response BandLoc Spinal Fixation is a medical device that received FDA 510(k) clearance on 2020-03-16. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K200097.

When was Response BandLoc Spinal Fixation approved by the FDA?

Response BandLoc Spinal Fixation received FDA 510(k) clearance on 2020-03-16, under approval number K200097.

What company makes Response BandLoc Spinal Fixation?

Response BandLoc Spinal Fixation is manufactured by OrthoPediatrics Corp..

What is the FDA product code for Response BandLoc Spinal Fixation?

The FDA product code for Response BandLoc Spinal Fixation is OWI.

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Other Devices by OrthoPediatrics Corp.

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Related Devices (Code: OWI)

K160698LigaPASSMedicrea International SA K161267Response BandLoc Spinal FixationOrthoPediatrics Corp. K161265NuVasive® VersaTie SystemNu Vasive, Incorporated K153348JAZZ LOCKImplanet, S.A. K160208NILE Alternative Fixation Spinal SystemK2m, Inc. K173117NuVasive® VersaTie™ SystemNuvasive, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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