510(k) Report

Devices descending from K081195

405 later devices reach Revere Uniplanar Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—