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Aesculap Sibd Xp Spinal System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111122

by Aesculap Implant Systems, Inc.

Identifiers

510(k) Number
K111122 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)

Aesculap Sibd Xp Spinal System by Aesculap Implant Systems, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K111122 24 fields · synced Jun 18, 2026