Atlas FDA

coflex-IF

FDA 510(k) clearance K153302 · decided 2016-09-08

Clearance details

K-number
K153302
Device name
coflex-IF
Applicant
Paradigm Spine, LLC
Decision
Substantially Equivalent
Date received
2015-11-13
Decision date
2016-09-08
Days to decision
300 days
Clearance type
Traditional
Product code
PEK
Device class
2
Regulation number
888.3050
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
New York, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.