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510(k) K200301

Device
UNiTi ACDF Implant System
Applicant
Pressio, Inc.
510(k) number
K200301
Product code
PHQ  
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-03
Date received
2020-02-06
Regulation
888.3060
Classification name
Anterior Staple As Supplemental Fixation For Fusion
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Joe Ritz
Address
14785 Omicron Dr., Suite 100 San Antonio TX US 78245 78245

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PHQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K133906C-JAWS CERVICAL COMPRESSIVE STAPLEMedicrea International2014-07-24

Legacy Summary#

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FDA Review#

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