FDA 510(k)

Oyster ACIF Cage

K-Number: K182608 · 2019-06-13

Decision Date2019-06-13

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Oyster ACIF Cage is a medical device manufactured by Silony Medical GmbH. It received FDA 510(k) clearance on 2019-06-13 under approval number K182608. 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 Oyster ACIF Cage?

Oyster ACIF Cage is a medical device that received FDA 510(k) clearance on 2019-06-13. It is manufactured by Silony Medical GmbH. The 510(k) number is K182608.

When was Oyster ACIF Cage approved by the FDA?

Oyster ACIF Cage received FDA 510(k) clearance on 2019-06-13, under approval number K182608.

What company makes Oyster ACIF Cage?

Oyster ACIF Cage is manufactured by Silony Medical GmbH.

What is the FDA product code for Oyster ACIF Cage?

The FDA product code for Oyster ACIF Cage is ODP.

Other Devices by Silony Medical GmbH

K171434ROCCIA® MultiLIF K162587ROCCIA® ACIF K181899ROCCIA® PLIF K180963ROCCIA ALIF, ROCCIA TLIF K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® System K190680FAVO S-TLIF

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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.