Atlas FDA

EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT

FDA 510(k) clearance K111379 · decided 2011-06-08

Clearance details

K-number
K111379
Device name
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
Applicant
Exactech, Inc.
Decision
Substantially Equivalent
Date received
2011-05-17
Decision date
2011-06-08
Days to decision
22 days
Clearance type
Special
Product code
KWS
Device class
2
Regulation number
888.3660
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
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mat recall (Z-1408-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Ma recall (Z-1409-2024)Exactech, Inc.2024-03-29

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