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Aesculap Implant Systems SIBD Spinal System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K100802

by Aesculap Implant Systems, Inc.

Identifiers

510(k) Number
K100802 FDA 510(k)
FDA Product Code
OVD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Aesculap Implant Systems SIBD Spinal System is a stand-alone spinal device designed for use with four supplied bone screws when no supplemental fixation is utilized. It is indicated for skeletally mature patients who have undergone at least six months of non-operative treatment and may have had previous non-fusion spinal surgery at the involved spinal level.

This device is supplied for clinical use and has received FDA 510(k) clearance. It is intended for use in patients meeting specific skeletal maturity and treatment history criteria as outlined in the technical documentation. Users should refer to the provided instructions for use for complete technical specifications and application guidance.

Frequently asked questions

What is the intended use of the Aesculap SIBD Spinal System?

This device is a stand-alone spinal system indicated for use in skeletally mature patients. It is specifically designed for individuals who have undergone at least six months of non-operative treatment and may have previously had non-fusion spinal surgery at the involved level.

Does the SIBD Spinal System require supplemental fixation?

No, the system is designed as a stand-alone device. It is intended for use with the four supplied bone screws, meaning no additional supplemental fixation is required when using this system.

What is the regulatory status of this spinal system?

The Aesculap SIBD Spinal System has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Instructions for Aesculap Implant Systems A-Space SIBD Spinal System, AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM (K100802) — FDA 510 (k ..., PDF Aesculap® Implant Systems, Aesculap Implant Systems, LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aesculap Implant Systems, Inc.

Sources (1)

  • FDA 510(k) K100802 24 fields · synced Sep 24, 2026