Atlas FDA

MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50

FDA 510(k) clearance K083447 · decided 2009-02-06

Clearance details

K-number
K083447
Device name
MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50
Applicant
Memometal Technologies
Decision
Substantially Equivalent
Date received
2008-11-21
Decision date
2009-02-06
Days to decision
77 days
Clearance type
Traditional
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Bruz, FR
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.