FDA 510(k)

ROCCIA® ACIF

K-Number: K162587 · 2017-01-26

Decision Date2017-01-26

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ROCCIA® ACIF is a medical device manufactured by Silony Medical GmbH. It received FDA 510(k) clearance on 2017-01-26 under approval number K162587. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCCIA® ACIF?

ROCCIA® ACIF is a medical device that received FDA 510(k) clearance on 2017-01-26. It is manufactured by Silony Medical GmbH. The 510(k) number is K162587.

When was ROCCIA® ACIF approved by the FDA?

ROCCIA® ACIF received FDA 510(k) clearance on 2017-01-26, under approval number K162587.

What company makes ROCCIA® ACIF?

ROCCIA® ACIF is manufactured by Silony Medical GmbH.

What is the FDA product code for ROCCIA® ACIF?

The FDA product code for ROCCIA® ACIF is ODP.

Other Devices by Silony Medical GmbH

K171434ROCCIA® MultiLIF K181899ROCCIA® PLIF K180963ROCCIA ALIF, ROCCIA TLIF K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® System K190680FAVO S-TLIF K182608Oyster ACIF Cage

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Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.