FDA 510(k)

ROCCIA® PLIF

K-Number: K181899 · 2018-12-13

Decision Date2018-12-13

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ROCCIA® PLIF is a medical device manufactured by Silony Medical GmbH. It received FDA 510(k) clearance on 2018-12-13 under approval number K181899. 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 ROCCIA® PLIF?

ROCCIA® PLIF is a medical device that received FDA 510(k) clearance on 2018-12-13. It is manufactured by Silony Medical GmbH. The 510(k) number is K181899.

When was ROCCIA® PLIF approved by the FDA?

ROCCIA® PLIF received FDA 510(k) clearance on 2018-12-13, under approval number K181899.

What company makes ROCCIA® PLIF?

ROCCIA® PLIF is manufactured by Silony Medical GmbH.

What is the FDA product code for ROCCIA® PLIF?

The FDA product code for ROCCIA® PLIF is MAX.

Other Devices by Silony Medical GmbH

K171434ROCCIA® MultiLIF K162587ROCCIA® ACIF K180963ROCCIA ALIF, ROCCIA TLIF K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® System K190680FAVO S-TLIF K182608Oyster ACIF Cage

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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

View on FDA Database →

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