FDA 510(k)

RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System

Numéro K : K193100 · 2020-03-24

Date de décision2020-03-24

Code produitNKB

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2020-03-24 under 510(k) number K193100. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System?

RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System is a medical device that received FDA 510(k) clearance on 2020-03-24. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K193100.

When did RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System receive FDA 510(k) clearance?

RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System received FDA 510(k) clearance on 2020-03-24, under 510(k) number K193100.

Who is the listed applicant for RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System?

The FDA 510(k) record lists OrthoPediatrics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System?

The FDA product code for RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System is NKB.

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Source officielle

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