Atlas FDA

LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X

FDA 510(k) clearance K082679 · decided 2009-04-07

Clearance details

K-number
K082679
Device name
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
Applicant
Sintea Biotech, Inc.
Decision
Substantially Equivalent
Date received
2008-09-15
Decision date
2009-04-07
Days to decision
204 days
Clearance type
Special
Product code
JEC
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Miami Beach, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.