Atlas FDA

LEFORTE SYSTEM BONE PLATE

FDA 510(k) clearance K023360 · decided 2002-10-25

Clearance details

K-number
K023360
Device name
LEFORTE SYSTEM BONE PLATE
Applicant
Jeil Medical Corporation
Decision
Substantially Equivalent
Date received
2002-10-07
Decision date
2002-10-25
Days to decision
18 days
Clearance type
Traditional
Product code
KTW
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Deer Field, IL, US
Third-party review
No
Expedited review
No

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SYNTHES (USA) MODULAR BLADE PLATE SYSTEM (K080109)Synthes (Usa)2008-03-20
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REPROCESSED EBI EXTERNAL FIXATION DEVICES (K012645)Alliance Medical Corp.2002-06-24
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Recalls involving this device

No recalls on record reference this clearance.