510(k) Report

Devices descending from K091623

7 later devices reach Laminoplasty Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231232Curiteva Laminoplasty SystemCuriteva, Inc.20232—
+1K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc.20160—
+1K130830Integra Laminoplasty SystemSeaspine, Inc.20132—
+2K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.20241—
+2K150469Integra Laminoplasty SystemSeaspine, Inc.20151—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—