Medical Device Manufacturer · US , Carlsbad , CA

Alphatec Spine, Inc.

92 submissions · 92 cleared · Since 2005
92
Total
92
Cleared
0
Denied

Alphatec Spine, Inc. — FDA 510(k) Submissions

Alphatec Spine, Inc. has submitted 92 FDA 510(k) premarket notifications since 2005, of which 92 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Bone Graft, Lumbar, Thoracolumbosacral Pedicle Screw System, Appliance, Fixation, Spinal Intervertebral Body, Orthopedic Stereotaxic Instrument, Orthosis, Spinal Pedicle Fixation . Use the specialty filter in the sidebar to narrow results.

92 devices
1–25 of 92
Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
K252597 · OLO Orthopedic Stereotaxic... · Orthopedic
Feb 2026 188d
SafeOp 3: Neural Informatix System
K252842 · GWF Stimulator, Electrical,... · Neurology
Jan 2026 125d
Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
K251965 · KWQ Appliance, Fixation,... · Orthopedic
Aug 2025 63d
IdentiTi II Cervical Interbody System
K251080 · ODP Intervertebral Fusion... · Orthopedic
Jul 2025 86d
Calibrate Interbody Systems
K243461 · Orthopedic
Mar 2025 116d
IdentiTi? II Interbody System
K242364 · MAX Intervertebral Fusion... · Orthopedic
Oct 2024 56d
Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
K242147 · MAX Intervertebral Fusion... · Orthopedic
Sep 2024 59d
Invictus? Small Stature Spinal Fixation System
K241519 · NKB Thoracolumbosacral... · Orthopedic
Jun 2024 23d
IntraOp Alignment System
K240199 · OWB Interventional... · Radiology
May 2024 118d
SafeOp 3: Neural Informatix Systeem
K234092 · GWF Stimulator, Electrical,... · Neurology
Apr 2024 115d
Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System
K233640 · KWQ Appliance, Fixation,... · Orthopedic
Feb 2024 101d
ATEC Posterior Navigated Disc Prep Instruments
K232345 · OLO Orthopedic Stereotaxic... · Orthopedic
Nov 2023 90d
Calibrate CCX Interbody System
K232504 · MAX Intervertebral Fusion... · Orthopedic
Oct 2023 56d
Invictus Robotic Navigation Instruments
K232044 · OLO Orthopedic Stereotaxic... · Orthopedic
Oct 2023 88d
Ascend VBR System, Ascend NanoTec VBR System
K232173 · MQP Spinal Vertebral Body... · Orthopedic
Oct 2023 77d
Invictus? Spinal Fixation System
K232275 · NKB Thoracolumbosacral... · Orthopedic
Sep 2023 58d
IdentiTi ALIF Interbody Systems
K232097 · OVD Intervertebral Fusion... · Orthopedic
Sep 2023 74d
Fusion Robotic Navigation System
K232413 · OLO Orthopedic Stereotaxic... · Orthopedic
Sep 2023 29d
Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System
K231438 · MAX Intervertebral Fusion... · Orthopedic
Jul 2023 57d
ATEC Lateral Plate System
K230721 · KWQ Appliance, Fixation,... · Orthopedic
May 2023 55d
Calibrate LTX Interbody System
K223611 · MAX Intervertebral Fusion... · Orthopedic
Mar 2023 117d
ATEC Lateral Navigation Instruments
K223765 · OLO Orthopedic Stereotaxic... · Orthopedic
Mar 2023 98d
Invictus? Bone Cement, Invictus Spinal Fixation System
K221926 · PML Bone Cement, Posterior... · Orthopedic
Dec 2022 172d
Calibrate LTX Interbody System
K222455 · MAX Intervertebral Fusion... · Orthopedic
Nov 2022 95d
IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem
K222973 · ODP Intervertebral Fusion... · Orthopedic
Nov 2022 50d

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