Oyster ACIF Cage

Q: When was Oyster ACIF Cage cleared by the FDA?

Oyster ACIF Cage (K182608) received a 510(k) decision of Substantially Equivalent on June 13, 2019, 265 days after the submission was received.

Q: What is the product code of K182608?

The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K182608 · Silony Medical GmbH

Substantially Equivalent

510(k) numberK182608

Submission

Device name: Oyster ACIF Cage
Applicant: Silony Medical GmbH
Leinfelden-Echterdingen, DE
Received: September 21, 2018
Decision date: June 13, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: ODP – Intervertebral Fusion Device With Bone Graft, Cervical
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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K253041	3d Cage CervicalODP · Traditional	Fims Co., Ltd.	07/23/2026SE
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K260840	BluEX Cervical Expandable Cage SystemODP · Traditional	L&K BIOMED Co., Ltd.	05/16/2026SE
K260850	Osteomni Spinal Cages SystemODP · Traditional	Osteomni, Inc.	05/12/2026SE
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K253260	ORIO-3D Cage SystemODP · Traditional	SpineCraft	04/16/2026SE
K260340	HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional	HC Biologics, LLC	04/13/2026SE

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Questions and answers

When was Oyster ACIF Cage cleared by the FDA?

Oyster ACIF Cage (K182608) received a 510(k) decision of Substantially Equivalent on June 13, 2019, 265 days after the submission was received.

What is the product code of K182608?

The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.