FDA.report

510(k) K222806

Device
Kodiak C Spinal Implant System
Applicant
Met One Technologies, LLC
510(k) number
K222806
Product code
ODP
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-22
Date received
2022-09-16
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Adrian Carbonell
Address
513 W. San Antonio Ave., Suite C El Paso TX US 79901 79901

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
0081982402761812x14mm, 10mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
00819824025133KODIAK CERVICAL IMPLANT, 12x14mm, 5mmx0°MET 1 TECHNOLOGIES, LLC2023-04-07
0081982402747212x14mm, 6° KODIAK CORPECTOMY TRIAL MET 1 TECHNOLOGIES, LLC2023-04-07
0081982402748914x16mm, 6° KODIAK CORPECTOMY TRIAL MET 1 TECHNOLOGIES, LLC2023-04-07
0081982402749612x14mm, 5mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402750212x14mm, 6mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402751912x14mm, 7mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402752612x14mm, 8mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402753312x14mm, 9mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402754012x14mm, 10mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402755712x14mm, 11mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402756412x14mm, 5mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402757112x14mm, 6mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402758812x14mm, 7mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402759512x14mm, 8mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402760112x14mm, 9mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402776214x16mm, 11mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402762512x14mm, 11mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402763214x16mm, 5mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402764914x16mm, 6mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402765614x16mm, 7mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402766314x16mm, 8mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402767014x16mm, 9mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402768714x16mm, 10mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402769414x16mm, 11mmx0° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402770014x16mm, 5mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402771714x16mm, 6mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402772414x16mm, 7mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402773114x16mm, 8mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07
0081982402774814x16mm, 9mmx6° KODIAK CERVICAL TRIALMET 1 TECHNOLOGIES, LLC2023-04-07

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