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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K172185

Tyber Medical PT Interbody Spacer System · Tyber Medical, LLC · decided 2017-12-21 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ACIS® ProTi 360°™108843110Tyber Medical, LLCODP00819917020052
CONCORDE® ProTi 360°™188827415Tyber Medical, LLCMAX00819917021356
CONCORDE® ProTi 360°™188827105Tyber Medical, LLCMAX00819917021080
ACIS® ProTi 360°™108843007Tyber Medical, LLCODP00819917020427
CONCORDE® ProTi 360°™188823114Tyber Medical, LLCMAX00819917020816
ACIS® ProTi 360°™108843009Tyber Medical, LLCODP00819917020441
ACIS® ProTi 360°™108843108Tyber Medical, LLCODP00819917020038
CONCORDE® ProTi 360°™188827115Tyber Medical, LLCMAX00819917021189
CONCORDE® ProTi 360°™188827410Tyber Medical, LLCMAX00819917021301
ACIS® ProTi 360°™108843509Tyber Medical, LLCODP00819917020601
ACIS® ProTi 360°™108843810Tyber Medical, LLCODP00819917020373
ACIS® ProTi 360°™108843706Tyber Medical, LLCODP00819917020250
ACIS® ProTi 360°™108843209Tyber Medical, LLCODP00819917020120
CONCORDE® ProTi 360°™188831211Tyber Medical, LLCMAX00819917021486
ACIS® ProTi 360°™108843505Tyber Medical, LLCODP00819917020564
CONCORDE® ProTi 360°™188835213Tyber Medical, LLCMAX00819917021592
CONCORDE® ProTi 360°™188827211Tyber Medical, LLCMAX00819917021233
ACIS® ProTi 360°™108843112Tyber Medical, LLCODP00819917020076
CONCORDE® ProTi 360°™188827207Tyber Medical, LLCMAX00819917021196
CONCORDE® ProTi 360°™188827106Tyber Medical, LLCMAX00819917021097
CONCORDE® ProTi 360°™188823210Tyber Medical, LLCMAX00819917020861
ACIS® ProTi 360°™108843011Tyber Medical, LLCODP00819917020465
ACIS® ProTi 360°™108843010Tyber Medical, LLCODP00819917020458
CONCORDE® ProTi 360°™188835208Tyber Medical, LLCMAX00819917021547
ACIS® ProTi 360°™108843511Tyber Medical, LLCODP00819917020625