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Instinct Java System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111301

by Zimmer Spine

Identifiers

510(k) Number
K111301 FDA 510(k)
FDA Product Code
NKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Instinct Java System by Zimmer Spine — 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

Manufacturer
Zimmer Spine

Sources (1)

  • FDA 510(k) K111301 24 fields · synced Jun 18, 2026