Atlas FDA

OCTANE-C INTERBODY FUSION DEVICE SYSTEM

FDA 510(k) clearance K103655 · decided 2011-06-30

Clearance details

K-number
K103655
Device name
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
Applicant
Exactech, Inc.
Decision
Substantially Equivalent
Date received
2010-12-15
Decision date
2011-06-30
Days to decision
197 days
Clearance type
Traditional
Product code
ODP
Device class
2
Regulation number
888.3080
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
Octane-C Cervical, 6 Lordotic Intended for anterior cervical spine intervertebral body fus recall (Z-2120-2012)Exactech, Inc.2012-07-31

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