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MODULAR THUMB IMPLANT - 17007

FDA 510(k)

Class II (US FDA 510(k))

510(k) K052596

by Biopro, Inc.

Identifiers

510(k) Number
K052596 FDA 510(k)
FDA Product Code
KYI FDA 510(k)
Models / Variants
17065 FDA 510(k)
17066 FDA 510(k)
17243 FDA 510(k)
17067 FDA 510(k)
17199 FDA 510(k)
17238 FDA 510(k)
17005 FDA 510(k)
17239 FDA 510(k)
17006 FDA 510(k)
17240 FDA 510(k)
17007 FDA 510(k)
17241 FDA 510(k)
17500 FDA 510(k)
17501 FDA 510(k)
17507 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3770 FDA 510(k)
Regulation Number
888.3770 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

MODULAR THUMB IMPLANT - 17007 by Biopro, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 15 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biopro, Inc.

Sources (1)

  • FDA 510(k) K052596 24 fields · synced Jun 18, 2026