Atlas FDA

DISTAL HUMERAL PLATES WITH ANGULAR STABILITY

FDA 510(k) clearance K080184 · decided 2008-03-26

Clearance details

K-number
K080184
Device name
DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
Applicant
I.T.S. Implantat-Technologie-Systeme GmbH
Decision
Substantially Equivalent
Date received
2008-01-25
Decision date
2008-03-26
Days to decision
61 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
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding recall (Z-1602-2026)I.T.S. GmbH2026-03-20