FDA 510(k)

Spinal Jaxx Interbody Fusion Device

Numéro K : K152501 · 2016-06-29

Date de décision2016-06-29

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Spinal Jaxx Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Neuropro Spinaljaxx, Inc.. It received FDA 510(k) clearance on 2016-06-29 under 510(k) number K152501. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Spinal Jaxx Interbody Fusion Device?

Spinal Jaxx Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2016-06-29. The listed applicant is Neuropro Spinaljaxx, Inc.. The 510(k) number is K152501.

When did Spinal Jaxx Interbody Fusion Device receive FDA 510(k) clearance?

Spinal Jaxx Interbody Fusion Device received FDA 510(k) clearance on 2016-06-29, under 510(k) number K152501.

Who is the listed applicant for Spinal Jaxx Interbody Fusion Device?

The FDA 510(k) record lists Neuropro Spinaljaxx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spinal Jaxx Interbody Fusion Device?

The FDA product code for Spinal Jaxx Interbody Fusion Device is MAX.

Essais cliniques associés

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Dispositifs connexes (Code : MAX)

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Source officielle

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