← Back to catalogue

Citregen Tendon Interference Screw and Citrelock

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200725

by Acuitive Technologies

Identifiers

510(k) Number
K200725 FDA 510(k)
FDA Product Code
MAI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Citregen Tendon Interference Screw and Citrelock by Acuitive Technologies — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Sources (1)

  • FDA 510(k) K200725 24 fields · synced Jun 18, 2026