Atlas FDA

SIGNATURE PLANNER / SIGNATURE GUIDES

FDA 510(k) clearance K110415 · decided 2011-05-16

Clearance details

K-number
K110415
Device name
SIGNATURE PLANNER / SIGNATURE GUIDES
Applicant
Materialise NV
Decision
Substantially Equivalent
Date received
2011-02-14
Decision date
2011-05-16
Days to decision
91 days
Clearance type
Traditional
Product code
HRY
Device class
2
Regulation number
888.3530
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Leuven, BE
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET recall (Z-0628-2014)Materialise USA LLC2014-01-03