Product code MAX— Orthopedic
FlareHawk Interbody Fusion System
- Advisory panel
- Orthopedic
- Total cleared
- 894
Adverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MAX
1–100 of 894- K253011 — Catalyft PL Expandable Interbody System
- K261020 — Symmetrix L Spinal System
- K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy
- K253151 — Fule Interbody Fusion Cage System
- K261159 — Exceed® Biplanar Expandable Interbody System
- K253894 — BMD Titanium Spinal Fusion System
- K260506 — Ventana® P/T Lumbar Interbody System
- K260837 — VersaLift Expandable System
- K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
- K261067 — BEE PLIF Cage
- K254017 — SWINGO-3D Lumbar Cage System
- K253583 — LUX Expandable Lumbar Interbody System
- K250773 — Luna® Ti Interbody Fusion System
- K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System
- K253266 — Titanium Interbody System
- K253577 — IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
- K252610 — ZSFab Lumbar Interbody System
- K252351 — UniSpace® TPLIF Cage
- K253377 — Expandable Titanium PLIF/TLIF System
- K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))
- K251444 — Endoskeleton Interbody Systems
- K251969 — Atlas Spine Project X Expandable Posterior Lumbar Interbody System
- K252113 — PRADO Lumbar Interbody Fusion System
- K251016 — MectaLIF 3D Metal
- K251741 — PathLoc Lumbar Interbody Fusion Cage System
- K250827 — aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams
- K251502 — TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
- K250987 — aprevo® posterior/transforaminal lumbar interbody fusion device
- K243816 — Testa TP Pivoting Spacer System
- K251003 — X-PAC® LLIF Expandable Lateral Cage System
- K251617 — X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System
- K243973 — FIX-L PEEK PLIF and T-PLIF System
- K251335 — Tera Lumbar Interbody Fusion System (Various PNs)
- K243116 — FlareHawk Interbody Fusion System
- K250669 — Adaptix Interbody System with Titan nanoLOCK Surface Technology
- K250373 — ProLift Expandable Spacer System
- K243074 — Spectrum Spine Lumbar Cage System
- K250667 — DeGen Medical Patient Specific Implant (PSI) System
- K250186 — GoLIF! Lumbar Interbody Fusion System
- K242771 — Tesera-k PL System and Tesera-k XL System
- K241783 — FortiVy OsteoVy Lumbar IBF
- K241375 — IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer
- K243739 — AxCess® Expandable Interbody System
- K243668 — ProLift Pivot Expandable Spacer System
- K243670 — Idys® LIF
- K241073 — DZ-Tabone Intervertebral Body Fusion Device
- K242589 — Scarlet® AL-T
- K242829 — BluEX Lumbar Expandable Cage System
- K233947 — KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System
- K242267 — Gemini Medical Cage System
- K242826 — ProLift Wedge Expandable Spacer System
- K242457 — EARP Interbody System
- K242364 — IdentiTi II Interbody System
- K240889 — ARTFX Lumbar PEEK Cages
- K233807 — LumiVy Lumbar IBF System
- K241332 — aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device
- K242147 — Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
- K242509 — HAnano InterFuse(R) Modular Interbody
- K240250 — 3D Printed PEEK Interbody System
- K241438 — Signus Tetris St; Signus Tetris R St
- K232996 — Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)
- K234035 — COSINE Spacer
- K241164 — IB3D PL Spinal System
- K241605 — Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology
- K241328 — aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)
- K240326 — Solar Lumbar Interbody Fusion System
- K241413 — sagAlign Lumbar Cage System (Various PNs)
- K234077 — SPIRA® Anterior Lumbar Spacers
- K241019 — aprevo® TLIF-C Articulating System
- K240830 — Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System
- K241466 — Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System
- K240749 — PILLAR SA Ti Spacer System (82-XXX)
- K240566 — Reef L Interbody System; WaveForm L Interbody System
- K233509 — Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
- K232792 — icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)
- K234150 — Lucent® XP
- K232282 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device
- K233375 — Tranquil-L Interbody System
- K233075 — BioGend Interbody Fusion System 001 Cage
- K234087 — restor3d TIDAL Lumbar Interbody Fusion System
- K233744 — Curiteva Porous PEEK Lumbar Interbody Fusion System
- K233694 — Meridian Interbody System; WaveForm A Interbody System
- K230872 — Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System
- K231743 — F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System
- K232611 — TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System
- K232069 — Expandable Lumbar Fusion Cage (Type I,Type II)
- K232292 — Peridot-EX Expandable Intervertebral Body Fusion System
- K232504 — Calibrate CCX Interbody System
- K232014 — CONDUIT ATP Inserters
- K231680 — AccelFix Lumbar Expandable Cage System
- K221894 — Lumbar Expandable lnterbody Spacers -Additional Indications/Implants
- K231275 — Exceed Biplanar Expandable Interbody System
- K231438 — Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System
- K231241 — NanoHive Medical Lumbar Interbody System
- K230942 — SPIRA® Posterior Lumbar Spacers
- K231252 — Ventana L Spinal System
- K231199 — Solar Lumbar Interbody Fusion System
- K231359 — RODIN Expandable Lumbar Cage System
- K230851 — Kodiak Lumbar Spacer System
- K231140 — aprevo® transforaminal lumbar interbody fusion device
Data sourced from openFDA. This site is unofficial and independent of the FDA.