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ROCCIA ACIF

by Silony Medical GmbH

510(k) K162587Ref RI-T04181305, RI-T04141305, RI-T04181505, RI-2060, RI-T06141351, RI-T08161505, RI-T05181551, RI-8060, RI-T06141305, RI-T05181351, RI-2061, RI-T07181305, RI-8010, RI-T06181505, RI-T07161305, RI-8050, RI-T08181551, RI-T07181351, RI-T08181351, RI-T08161305, RI-T04161551, RI-T04161351, RI-T04161305, RI-T07181551

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162587↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04054896015682 UDI-DI Date18 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4054896TRIALS52 Basic UDI-DI Date20 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK162587 Date26 Jan 2017ClearedStatusActive

Certificates

0 certificates · EUDAMED

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

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Roccia Acif EUDAMED
Inserter GUDID
Pusher GUDID
Loading Block GUDID
Generic Name
Orthopaedic implant impactor, reusable
General internal orthopaedic fixation system implantation kit
Bone graft packing block
Device Name
Trial
Mallet
Model / Ref / Catalog
RI-T04181305, RI-T04141305, RI-T04181505, RI-2060, RI-T06141351, RI-T08161505, RI-T05181551, RI-8060, RI-T06141305, RI-T05181351, RI-2061, RI-T07181305, RI-8010, RI-T06181505, RI-T07161305, RI-8050, RI-T08181551, RI-T07181351, RI-T08181351, RI-T08161305, RI-T04161551, RI-T04161351, RI-T04161305, RI-T07181551
Primary DI / UDI-DI
04054896015682, 04054896015651, 04054896015699, 04054896015583, 04054896021959, 04054896015873, 04054896021942, 04054896022277, 04054896015750, 04054896021935, 04054896015590, 04054896015835, 04054896021591, 04054896015798, 04054896015811, 04054896015576, 04054896022093, 04054896022031, 04054896022086, 04054896015866, 04054896021874, 04054896021867, 04054896015668, 04054896022048
Basic UDI-DI
4054896TRIALS52, 4054896LOADINGBLOCKLJ, 4054896MALLETW2, 4054896PUSHER6Z, 4054896INSERTERG2
510(k) Number
FDA Product Code
ODP 510(k)
LXH GUDID
EMDN Code
L091099, L091002, L0903, L091199, L091001
GMDN Term
Orthopaedic implant impactor, reusable
General internal orthopaedic fixation system implantation kit
Bone graft packing block
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

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
FDA Product CodeEUDAMED
—
510(k)
ODP
GUDID
LXH
Device ClassEUDAMED
Class IIa
Class I
510(k)
Class II
GUDID
Class I
Regulation NumberEUDAMED
—
510(k)
888.3080
GUDID
888.4540

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ROCCIA ACIF is a cervical interbody fusion device designed for anterior cervical stabilization and restoration of physiological lordosis. Classified under the product code ODP, it is intended for use in spinal surgeries to maintain disc height and promote fusion in the cervical spine.

Supplied sterile and intended for single-use, the ROCCIA ACIF is available in a wedge-shaped cage size of 5x18x15mm. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with accompanying instruments featuring a non-reflective black coating for compatibility with surgical microscopes. Storage and handling follow manufacturer guidelines outlined in the provided instructions for use.

Other devices from Silony Medical GmbH

See all devices from Silony Medical GmbH →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ROCCIA ACIF designed to achieve in cervical spine surgeries and how does its shape contribute to this purpose?

    The ROCCIA ACIF is specifically designed for anterior cervical stabilization to maintain disc height and restore physiological lordosis in the cervical spine. Its wedge-shaped cage (5x18x15mm) is engineered to provide structural support while promoting spinal fusion, helping to align the vertebrae naturally and reduce postoperative instability.

  • Is the ROCCIA ACIF reusable, or is it intended for single-use only? How does this affect its sterility?

    The ROCCIA ACIF is supplied sterile and explicitly intended for single-use only. This design ensures patient safety by eliminating the risk of cross-contamination or degradation from repeated sterilization processes, which could compromise its structural integrity or sterility.

  • What surgical tools are included with the ROCCIA ACIF, and why is their coating important during procedures?

    The ROCCIA ACIF comes with accompanying instruments that feature a non-reflective black coating. This coating is specifically designed to reduce glare and improve visibility under surgical microscopes, enhancing precision during implantation in the cervical spine.

  • How should the ROCCIA ACIF be stored, and what guidelines should clinicians follow to maintain its integrity?

    Storage and handling instructions for the ROCCIA ACIF are detailed in the instructions for use provided by Silony Medical. Clinicians should follow these guidelines to preserve sterility, prevent damage, and ensure the device remains effective for its intended single-use application in spinal surgeries.

Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No