FDA 510(k)

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

K-Number: K162358 · 2016-11-01

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 a medical device manufactured by Synthes USA Products, LLC. It received FDA 510(k) clearance on 2016-11-01 under approval 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. It is manufactured by Synthes USA Products, LLC. The 510(k) number is K162358.

When was T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System approved by the FDA?

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

What company makes 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 manufactured by Synthes USA Products, LLC.

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 PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Synthes USA Products, LLC

K170818Craniomaxillofacial Distraction System (CMFD) K162594Craniomaxillofacial Distraction System (CMFD) K170654USS System K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw K180541DePuy Synthes 2.0 mm Quick Insertion Screws

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

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