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

Clearance record K221050

ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System · Aegis Spine, Inc. · decided 2022-06-30 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Paeon Posterior Cervical Fixation System6142-3169SAegis Spine, Inc.NKG00840273318422
Paeon Posterior Cervical Fixation System6139-3545SAegis Spine, Inc.NKG00840273317746
Paeon Posterior Cervical Fixation System6126-51025SAegis Spine, Inc.NKG00840273316893
Paeon Posterior Cervical Fixation System6125-41535SAegis Spine, Inc.NKG00840273316732
Paeon Posterior Cervical Fixation System6121-3515SAegis Spine, Inc.NKG00840273315926
Paeon Posterior Cervical Fixation System6116-3546SAegis Spine, Inc.NKG00840273314530
Paeon Posterior Cervical Fixation System6115-3512SAegis Spine, Inc.NKG00840273313526
Paeon Posterior Cervical Fixation System6112-4026SAegis Spine, Inc.NKG00840273313380
Paeon Posterior Cervical Fixation System6122-3506SAegis Spine, Inc.NKG00840273316251
Paeon Posterior Cervical Fixation System6118-3548SAegis Spine, Inc.NKG00840273315261
Paeon Posterior Cervical Fixation System6142-2158SAegis Spine, Inc.NKG00840273318149
Paeon Posterior Cervical Fixation System6121-3517SAegis Spine, Inc.NKG00840273315940
Paeon Posterior Cervical Fixation System6121-3505SAegis Spine, Inc.NKG00840273315827
Paeon Posterior Cervical Fixation System6116-3550SAegis Spine, Inc.NKG00840273314554
Paeon Posterior Cervical Fixation System6113-4046SAegis Spine, Inc.NKG00840273314325
Paeon Posterior Cervical Fixation System6114-3544SAegis Spine, Inc.NKG00840273312840
Paeon Posterior Cervical Fixation System6202-5550Aegis Spine, Inc.NKG00840273319078
Paeon Posterior Cervical Fixation System6142-3269SAegis Spine, Inc.NKG00840273318514
Paeon Posterior Cervical Fixation System6142-1040SAegis Spine, Inc.NKG00840273317982
Paeon Posterior Cervical Fixation System6134-3565SAegis Spine, Inc.NKG00840273317470
Paeon Posterior Cervical Fixation System6121-3510SAegis Spine, Inc.NKG00840273315872
Paeon Posterior Cervical Fixation System6112-4040SAegis Spine, Inc.NKG00840273313458
Paeon Posterior Cervical Fixation System6201-5050Aegis Spine, Inc.NKG00840273318798
Paeon Posterior Cervical Fixation System6201-5045Aegis Spine, Inc.NKG00840273318781
Paeon Posterior Cervical Fixation System6134-3580SAegis Spine, Inc.NKG00840273317487