510(k) Report

Devices descending from K955348

1,019 later devices reach Titanium Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+9K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+9K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+9K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+10K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K250769Dakota LP SystemPrecision Spine, Inc.20250—
+10K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K230329F3D Interbody SystemCorelink, LLC20230—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+12K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—