Favo S-Tlif

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 23 Oct 2026.

Trade Name

Favo S-Tlif EUDAMED

Inserter GUDID

Distractor GUDID

Scraper and Shaver GUDID

Generic Name

Orthopaedic implant impactor, reusable

General internal orthopaedic fixation system implantation kit

Bone curette, reusable

Device Name

Trial

Scraper & Shaver

Model / Ref / Catalog

FI-T14112805, FI-T15112815, FI-4112, FI-4211, FI-T13112815, FI-T10112800, FI-4113, FI-4108, FI-T11112815, FI-4206, FI-4020, FI-T16112810, FI-T09112810, FI-4214, FI-T15112800, FI-T11112805, FI-4109, FI-T07112800, FI-4106, FI-T14112800, FI-T15112810, FI-4118, FI-T12112810, FI-4207, FI-T10112810, FI-T10112805, FI-T15112805, FI-4218, FI-4114, FI-4117, FI-T17112805, FI-4020.2, FI-T12112805, FI-T09112805

Primary DI / UDI-DI

04054896073316, 04054896073392, 04054896073484, 04054896073606, 04054896073378, 04054896078106, 04054896073491, 04054896073446, 04054896073354, 04054896073552, 04054896073682, 04054896078250, 04054896078182, 04054896073637, 04054896078151, 04054896073286, 04054896073453, 04054896078076, 04054896073422, 04054896078144, 04054896078243, 04054896073545, 04054896078212, 04054896073569, 04054896078199, 04054896073279, 04054896073323, 04054896073675, 04054896073507, 04054896073538, 04054896073347, 04054896073705, 04054896073293, 04054896073262

Basic UDI-DI

4054896TRIALS52, 4054896SCRAPERANDSHAVER5C, 4054896DISTRACTOREQ, 4054896INSERTERG2

510(k) Number

K190680 ↗

FDA Product Code

MAX 510(k)

LXH GUDID

EMDN Code

L091099, L0901, L091002, L091001

GMDN Term

Orthopaedic implant impactor, reusable

General internal orthopaedic fixation system implantation kit

Bone curette, reusable

Device Class

Class IIa EUDAMED

Class I EUDAMEDGUDID

Class II 510(k)

Regulation

21 CFR Part 888.3080 510(k)

888.4540 GUDID

EU market of registration

Germany

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

• ROCCIA MultiLIF, ALIF, TLIF

  Class IIa

  CE/MDR

• Verticale

  Class IIa

  CE/MDR

• Storage Elements

  Class I

  CE/MDR

• VERTICALE SI/Triangular Fixation

  Class I

  CE/MDR

• VERTICALE Cervical

  Class IIa

  CE/MDR

• Oyster ACIF

  Class IIa

  CE/MDR

See all devices from Silony Medical GmbH →

• What materials is the FAVO S-TLIF Cage made from and why does that matter for spinal fusion procedures?

  The FAVO S-TLIF Cage is made from titanium alloy (ASTM F136 / ISO 5832-3), a biocompatible material commonly used in spinal implants. Titanium alloy offers excellent corrosion resistance, strength-to-weight ratio, and compatibility with bone tissue, which helps promote osseointegration—the process where bone grows directly onto the implant surface—for successful spinal fusion.

• Is the FAVO S-TLIF Cage designed for reuse or single-use, and how should it be handled to maintain sterility?

  The FAVO S-TLIF Cage is intended for single-use only. It is supplied sterile via gamma irradiation (compliant with EN ISO 11607) in a sealed package. To preserve sterility, the package should remain unopened until immediate preoperative use and handled with sterile techniques, avoiding contamination from surfaces or personnel.

• What specific design features of the FAVO S-TLIF Cage help improve spinal alignment during anterior lumbar interbody fusion (ALIF)?

  The FAVO S-TLIF Cage features an oblique lordotic angle and an offset bullet nose, which are engineered to enhance sagittal alignment and facilitate better bone integration in the lumbar spine. These design elements help restore natural spinal curvature while promoting stable fusion by optimizing contact with vertebral endplates.

• How is the FAVO S-TLIF Cage regulated, and what does the product code ‘MAX’ indicate about its classification?

  The FAVO S-TLIF Cage is regulated under FDA 510(k) clearance (K190680) and MDR compliance, with a product code of ‘MAX’—a classification under FDA’s orthopedic device hierarchy. The ‘MAX’ code signifies it is a major orthopedic device, typically requiring rigorous premarket review due to its role in spinal stabilization and fusion procedures.