Atlas FDA

OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS

FDA 510(k) clearance K132161 · decided 2013-10-11

Clearance details

K-number
K132161
Device name
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS
Applicant
Exactech, Inc.
Decision
Substantially Equivalent
Date received
2013-07-12
Decision date
2013-10-11
Days to decision
91 days
Clearance type
Traditional
Product code
JWH
Device class
2
Regulation number
888.3560
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Gainesville, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

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PMA approvals by this applicant

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NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S021)Exactech, Inc.2017-04-03
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S020)Exactech, Inc.2016-09-28
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S019)Exactech, Inc.2016-07-21
NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S017)Exactech, Inc.2016-04-26
NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S018)Exactech, Inc.2015-12-30
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S016)Exactech, Inc.2014-06-18
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S015)Exactech, Inc.2013-02-07
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S014)Exactech, Inc.2012-12-05