Favo S-Tlif

Q: When was Favo S-Tlif cleared by the FDA?

Favo S-Tlif (K190680) received a 510(k) decision of Substantially Equivalent on July 18, 2019, 122 days after the submission was received.

Q: What is the product code of K190680?

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) K190680 · Silony Medical GmbH

Substantially Equivalent

510(k) numberK190680

Submission

Device name: Favo S-Tlif
Applicant: Silony Medical GmbH
Leinfelden-Echterdingen, DE
Received: March 18, 2019
Decision date: July 18, 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: 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.

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Questions and answers

When was Favo S-Tlif cleared by the FDA?

Favo S-Tlif (K190680) received a 510(k) decision of Substantially Equivalent on July 18, 2019, 122 days after the submission was received.

What is the product code of K190680?

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.