Atlas FDA

EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER

FDA 510(k) clearance K071738 · decided 2007-08-15

Clearance details

K-number
K071738
Device name
EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER
Applicant
Exactech, Inc.
Decision
Substantially Equivalent
Date received
2007-06-26
Decision date
2007-08-15
Days to decision
50 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

RecordFirmDate
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, si recall (Z-0953-2013)Exactech, Inc.2013-03-15
OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***M recall (Z-2234-2012)Exactech, Inc.2012-08-21

PMA approvals by this applicant

RecordFirmDate
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