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FDA 510(k)

PUMA System

K-Number: K171703 · 2018-03-01

ApplicantPanther Orthopedics, Inc.
Decision Date2018-03-01
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PUMA System is a medical device manufactured by Panther Orthopedics, Inc.. It received FDA 510(k) clearance on 2018-03-01 under approval number K171703. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUMA System?

PUMA System is a medical device that received FDA 510(k) clearance on 2018-03-01. It is manufactured by Panther Orthopedics, Inc.. The 510(k) number is K171703.

When was PUMA System approved by the FDA?

PUMA System received FDA 510(k) clearance on 2018-03-01, under approval number K171703.

What company makes PUMA System?

PUMA System is manufactured by Panther Orthopedics, Inc..

What is the FDA product code for PUMA System?

The FDA product code for PUMA System is HTN.

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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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