Atlas FDA

ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)

FDA 510(k) clearance K083654 · decided 2009-02-26

Clearance details

K-number
K083654
Device name
ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2008-12-10
Decision date
2009-02-26
Days to decision
78 days
Clearance type
Special
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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