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FDA 510(k)

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

K-Number: K162358 · 2016-11-01

ApplicantSynthes USA Products, LLC
Decision Date2016-11-01
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes USA Products, LLC. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K162358. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System?

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Synthes USA Products, LLC. The 510(k) number is K162358.

When did T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System receive FDA 510(k) clearance?

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System received FDA 510(k) clearance on 2016-11-01, under 510(k) number K162358.

Who is the listed applicant for T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System?

The FDA 510(k) record lists Synthes USA Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System?

The FDA product code for T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System is MAX.

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Related Devices (Code: MAX)

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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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