FDA 510(k)

DePuy Synthes T-PAL Spacer System

K-Number: K181231 · 2018-12-06

Decision Date2018-12-06

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DePuy Synthes T-PAL Spacer System is a medical device manufactured by Depuy Synthes Spine. It received FDA 510(k) clearance on 2018-12-06 under approval number K181231. 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 DePuy Synthes T-PAL Spacer System?

DePuy Synthes T-PAL Spacer System is a medical device that received FDA 510(k) clearance on 2018-12-06. It is manufactured by Depuy Synthes Spine. The 510(k) number is K181231.

When was DePuy Synthes T-PAL Spacer System approved by the FDA?

DePuy Synthes T-PAL Spacer System received FDA 510(k) clearance on 2018-12-06, under approval number K181231.

What company makes DePuy Synthes T-PAL Spacer System?

DePuy Synthes T-PAL Spacer System is manufactured by Depuy Synthes Spine.

What is the FDA product code for DePuy Synthes T-PAL Spacer System?

The FDA product code for DePuy Synthes T-PAL Spacer System is MAX.

Other Devices by Depuy Synthes Spine

K183054SYNMESH System

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.