Roccia® Plif

Q: When was Roccia® Plif cleared by the FDA?

Roccia® Plif (K181899) received a 510(k) decision of Substantially Equivalent on December 13, 2018, 150 days after the submission was received.

Q: What is the product code of K181899?

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

FDA 510(k) K181899 · Silony Medical GmbH

Substantially Equivalent

510(k) numberK181899

Submission

Device name: Roccia® Plif
Applicant: Silony Medical GmbH
Leinfelden-Echterdingen, DE
Received: July 16, 2018
Decision date: December 13, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

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

Other 510(k)s with product code MAX

510(k)	Device	Applicant	Decision
K261049	Scala® TLMAX · Traditional	Spineart SA	08/20/2026SE
K261430	TruLift Expandable SystemMAX · Traditional	Life Spine, Inc.	07/28/2026SE
K253011	Catalyft PL Expandable Interbody SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/17/2026SE
K261020	Symmetrix L Spinal SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/14/2026SE
K253420	Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional	SeaSpine Orthopedics Corporation	07/01/2026SE
K253151	Fule Interbody Fusion Cage SystemMAX · Traditional	Beijing Fule Science & Technology Development…	06/15/2026SE
K261159	Exceed® Biplanar Expandable Interbody SystemMAX · Traditional	Spine Wave, Inc.	05/29/2026SE
K253894	BMD Titanium Spinal Fusion SystemMAX · Traditional	Global Biomedica s.r.o.	05/28/2026SE
K260506	Ventana® P/T Lumbar Interbody SystemMAX · Traditional	Spinal Elements, Inc.	05/15/2026SE
K260837	VersaLift Expandable SystemMAX · Traditional	Life Spine, Inc.	05/12/2026SE

More from Life Spine, Inc.

510(k)	Device	Decision
K253921	VERTICALE® Navigation InstrumentsOLO · Traditional	06/26/2026SE
K254148	VERTICALE GPS InstrumentsOLO · Traditional	02/19/2026SE
K223806	VERTICALE® Triangular Fixation SystemNKB · Traditional	07/06/2023SE
K223649	VERTICALE® Navigation InstrumentsOLO · Special	12/22/2022SE
K212007	VERTICALE Navigation InstrumentsOLO · Traditional	08/12/2021SE
K192013	VERTICALE® Cervical SystemNKG · Traditional	04/07/2020SE
K190680	Favo S-TlifMAX · Traditional	07/18/2019SE
K182608	Oyster ACIF CageODP · Traditional	06/13/2019SE
K180963	Roccia Alif, Roccia TlifMAX · Traditional	07/11/2018SE
K171421	VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemNKB · Traditional	01/10/2018SE

Questions and answers

When was Roccia® Plif cleared by the FDA?

Roccia® Plif (K181899) received a 510(k) decision of Substantially Equivalent on December 13, 2018, 150 days after the submission was received.

What is the product code of K181899?

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