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

Clearance record K210035

ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System · Aegis Spine · decided 2021-02-16 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ZESPIN SI Joint Fusion System1023-8040SAegis Spine, Inc.OUR00840273311966
Paeon Posterior Cervical Fixation System6142-2239Aegis Spine, Inc.NKG00840273310204
Paeon Posterior Cervical Fixation System6141-1003Aegis Spine, Inc.NKG00840273309925
Paeon Posterior Cervical Fixation System6136-3580Aegis Spine, Inc.NKG00840273309710
Paeon Posterior Cervical Fixation System6125-62015Aegis Spine, Inc.NKG00840273308959
Paeon Posterior Cervical Fixation System6125-61520Aegis Spine, Inc.NKG00840273308775
Paeon Posterior Cervical Fixation System6119-3518Aegis Spine, Inc.NKG00840273307563
Paeon Posterior Cervical Fixation System6117-4036Aegis Spine, Inc.NKG00840273307143
Paeon Posterior Cervical Fixation System6116-4026Aegis Spine, Inc.NKG00840273306757
Paeon Posterior Cervical Fixation System6115-3544Aegis Spine, Inc.NKG00840273305798
Paeon Posterior Cervical Fixation System6112-4012Aegis Spine, Inc.NKG00840273305422
Paeon Posterior Cervical Fixation System6112-4010Aegis Spine, Inc.NKG00840273305415
Elatus Lumbar Plate System7101-6030SAegis Spine, Inc.KWQ00840273302483
Elatus Lumbar Plate System7102-6050SAegis Spine, Inc.KWQ00840273302360
ZESPIN SI Joint Fusion System1023-8055SAegis Spine, Inc.OUR00840273311997
ZESPIN SI Joint Fusion System1023-6040Aegis Spine, Inc.OUR00840273311300
Paeon Posterior Cervical Fixation System6142-3149Aegis Spine, Inc.NKG00840273310471
Paeon Posterior Cervical Fixation System6126-51540Aegis Spine, Inc.NKG00840273309246
Paeon Posterior Cervical Fixation System6123-3503Aegis Spine, Inc.NKG00840273308126
Paeon Posterior Cervical Fixation System6119-3520Aegis Spine, Inc.NKG00840273307570
Paeon Posterior Cervical Fixation System6118-4044Aegis Spine, Inc.NKG00840273307525
Paeon Posterior Cervical Fixation System6116-3514Aegis Spine, Inc.NKG00840273306481
Paeon Posterior Cervical Fixation System6113-3540Aegis Spine, Inc.NKG00840273306191
Paeon Posterior Cervical Fixation System6115-3532Aegis Spine, Inc.NKG00840273305736
Paeon Posterior Cervical Fixation System6114-4040Aegis Spine, Inc.NKG00840273305149