Atlas FDA

PFX SPINOUS PROCESS FIXATION SYSTEM

FDA 510(k) clearance K132765 · decided 2014-07-14

Clearance details

K-number
K132765
Device name
PFX SPINOUS PROCESS FIXATION SYSTEM
Applicant
Innovasis, Inc.
Decision
Substantially Equivalent
Date received
2013-09-04
Decision date
2014-07-14
Days to decision
313 days
Clearance type
Traditional
Product code
PEK
Device class
2
Regulation number
888.3050
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Salt Lake City, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.