510(k) Report

Devices descending from K161535

14 later devices reach SeaSpine® NewPort™ Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+1K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+2K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+2K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+2K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+3K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—