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

Clearance record K100742

EXACTECH GPS · Blue Ortho · decided 2010-10-21 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
EXACTECHGPSJ00011Exactech, Inc.HAW10885862144218
Truliant02-521-10-0008Exactech, Inc.HAW OLO10885862564795
(unnamed)02-521-90-9999Exactech, Inc.HAW OLO10885862534279
EXACTECHGPSA10006Exactech, Inc.HAW10885862144270
(unnamed)521-30-04Exactech, Inc.HAW OLO10885862092885
EXACTECHGPSA10012Exactech, Inc.HAW10885862266651
(unnamed)521-30-09Exactech, Inc.HAW OLO10885862546371
(unnamed)521-40-13Exactech, Inc.HAW OLO10885862237552
(unnamed)02-521-10-0002Exactech, Inc.HAW OLO10885862546470
(unnamed)521-11-02Exactech, Inc.HAW OLO10885862092823
(unnamed)521-30-02Exactech, Inc.HAW OLO10885862092861
(unnamed)521-40-09Exactech, Inc.HAW OLO10885862257796
(unnamed)521-40-17Exactech, Inc.HAW OLO10885862252029
Truliant02-521-20-2004Exactech, Inc.HAW OLO10885862584106
GPS02-521-78-0000Exactech, Inc.HAW OLO10885862564801
(unnamed)521-30-08Exactech, Inc.HAW OLO10885862546364
GPS02-521-10-0004Exactech, Inc.HAW OLO10885862564757
(unnamed)521-40-11Exactech, Inc.HAW OLO10885862234148
EXACTECHGPSA10007Exactech, Inc.HAW10885862144294
GPS521-10-45Exactech, Inc.HAW OLO10885862092793
(unnamed)521-50-05Exactech, Inc.HAW OLO10885862295521
EXACTECHGPSI00020Exactech, Inc.HAW10885862252821
(unnamed)521-30-01Exactech, Inc.HAW OLO10885862092854
(unnamed)521-40-14Exactech, Inc.HAW OLO10885862252838
GPS02-521-20-1003Exactech, Inc.HAW OLO10885862564719