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Cem-Ostetic (Cemo-020o +4 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022622

by Berkeley Advanced Biomaterials, Inc.

Identifiers

510(k) Number
K022622 FDA 510(k)
FDA Product Code
MQV FDA 510(k)
Models / Variants
Cemo-020o FDA 510(k)
Cemo-05p FDA 510(k)
Cemo-10p FDA 510(k)
Cemo-20p FDA 510(k)
Cemo-30p FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3045 FDA 510(k)
Regulation Number
888.3045 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Cem-Ostetic (Cemo-020o +4 more) by Berkeley Advanced Biomaterials, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 5 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Berkeley Advanced Biomaterials, Inc.

Sources (1)

  • FDA 510(k) K022622 24 fields · synced Jun 18, 2026