Atlas FDA

VOLAR RADIUS PLATE WITH ANGULAR STABILITY

FDA 510(k) clearance K033756 · decided 2004-02-06

Clearance details

K-number
K033756
Device name
VOLAR RADIUS PLATE WITH ANGULAR STABILITY
Applicant
I.T.S. Implantat-Technologie-Systeme GmbH
Decision
Substantially Equivalent
Date received
2003-12-01
Decision date
2004-02-06
Days to decision
67 days
Clearance type
Traditional
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Prior Lake, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Volar Radius Plate with Angular Stability with the following description: Radius Plate PRO recall (Z-1592-2026)I.T.S. GmbH2026-03-20