Atlas FDA

STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM

FDA 510(k) clearance K060156 · decided 2006-03-20

Clearance details

K-number
K060156
Device name
STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM
Applicant
I.T.S. Implantat-Technologie-Systeme GmbH
Decision
Substantially Equivalent
Date received
2006-01-20
Decision date
2006-03-20
Days to decision
59 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
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding recall (Z-1598-2026)I.T.S. GmbH2026-03-20
I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Canc recall (Z-1599-2026)I.T.S. GmbH2026-03-20