510(k) Report

Devices descending from K163604

12 later devices reach SeaSpine® Daytona® Small Stature Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+1K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+1K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+2K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+2K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+2K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+3K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—