Oyster ACIF Cage

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

Oyster ACIF EUDAMED

Inserter GUDID

Generic Name

Orthopaedic implant impactor, reusable

Device Name

Trial

Model / Ref / Catalog

OI-T04171451, OI-T09171651, OI-T06171605, OI-T06151451, OI-T10171405, OI-T05171605, OI-T08171651, OI-T07151451, OI-T06171451, OI-T08151451, OI-1180, OI-T04151405, OI-T10171605, OI-T06171651, OI-T07171651, OI-T07171605, OI-T04171605, OI-T09171405, OI-T06151405, OI-T07171451, OI-T04171405, OI-1080.1, OI-T08171405, OI-T08171605, OI-T08151405, OI-T05151451, OI-T09171605, OI-T05171651, OI-T09151451

Primary DI / UDI-DI

04054896074542, 04054896074528, 04054896074702, 04054896074429, 04054896074818, 04054896074696, 04054896074511, 04054896074436, 04054896074566, 04054896074443, 04054896103594, 04054896074610, 04054896074740, 04054896074498, 04054896074504, 04054896074719, 04054896074689, 04054896074801, 04054896074634, 04054896074573, 04054896074757, 04054896103587, 04054896074795, 04054896074726, 04054896074658, 04054896074412, 04054896074733, 04054896074481, 04054896074450

Basic UDI-DI

4054896TRIALS52, 4054896INSERTERG2

510(k) Number

K182608 ↗

FDA Product Code

ODP 510(k)

LXH GUDID

EMDN Code

L091099, L091001

GMDN Term

Orthopaedic implant impactor, 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 types of spinal procedures is the Oyster ACIF Cage intended for, and how does it function during surgery?

  The Oyster ACIF Cage is specifically designed for anterior single or multi-level cervical interbody fusion procedures. It works by restoring the intervertebral height—essentially filling the space between vertebrae—to maintain proper spinal alignment. When combined with autograft or allograft materials, it promotes spinal segment stability through osteosynthesis (bone fusion), helping to stabilize the cervical spine and support long-term healing.

• Is the Oyster ACIF Cage reusable, or is it meant for single-use only? How is it supplied?

  The Oyster ACIF Cage is sterile and intended for single-use only. It is supplied pre-sterilized to ensure safety and efficacy in surgical settings, eliminating the need for reprocessing or reuse. This aligns with best practices for spinal implants to reduce infection risks and maintain device integrity.

• What size options are available for the Oyster ACIF Cage, and how might this affect its use in different patients?

  The Oyster ACIF Cage comes in varying footprint dimensions, ranging from 15 mm (anterior-posterior) × 15 mm (medial-lateral) up to larger sizes. These options allow surgeons to select the appropriate cage size based on the patient’s anatomy and the specific cervical levels being fused, ensuring a better fit for spinal stability and fusion success.

• How should the Oyster ACIF Cage be stored before use, and what precautions should be taken?

  Since the Oyster ACIF Cage is sterile and single-use, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until immediately before use to preserve sterility. Always follow the manufacturer’s instructions for storage to prevent contamination or damage.