Spineology, Inc.
Spineology, Inc. holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2025, with 1 FDA device recall on record.
Top product codes for Spineology, Inc.
FDA recalls by Spineology, Inc.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Spineology, Inc.
- K251302 — OptiMesh Multiplanar Expandable Interbody Fusion System
- K251943 — Spineology Navigation Instruments
- K230927 — OptiMesh Multiplanar Expandable Interbody Fusion System
- K231781 — OptiMesh Multiplanar Expandable Interbody Fusion System
- K213876 — Spineology Navigation Instruments
- K210155 — Duo Expandable Interbody Fusion System
- DEN200010 — Spineology Interbody Fusion System
- K192047 — Rampart One Lumbar Interbody Fusion System
- K191091 — Rampart One Lumbar Interbody Fusion System
- K190055 — Duo Lumbar Interbody Fusion Device
- K182322 — Duo Lumbar Interbody Fusion Device
- K182345 — Spineology Navigation Instruments
- K181792 — Duo Lumbar Interbody Fusion Device
- K180796 — Spineology Navigation Instruments
- K180002 — Rampart One Lumbar Interbody Fusion Device
- K172518 — Spineology Navigation Instruments
- K172107 — Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular Fixation System, Palisade Pedicular Fixation System
- K171660 — Duo Lumbar Interbody Fusion Device
- K171724 — Rampart L Lumbar Interbody Fusion Device
- K171438 — Palisade Pedicular Fixation System
- K163670 — Rampart One Lumbar Interbody Fusion Device
- K170251 — Threshold Pedicular Fixation System
- K170255 — Threshold V2 Pedicular Fixation System
- K170266 — Palisade Pedicular Fixation System
- K170268 — Fortress Pedicular Fixation System
- K163409 — Rampart(TM) T Lumbar Interbody Fusion Device
- K162879 — Elite Expandable Interbody Fusion Device
- K160074 — Rampart D Lumbar Interbody Fusion Device
- K161694 — Threshold Pedicular Fixation System
- K160906 — Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device
- K160980 — Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
- K153323 — Palisade Pedicular Fixation System
- K153082 — Rampart A Lumbar Interbody Fusion Device
- K152148 — Fortress Pedicular Fixation System
- K151020 — Rampart-T Interbody Fusion System
- K143403 — Threshold Pedicular Fixation System
- K142213 — VIA SPINOUS PROCESS FIXATION SYSTEM
- K140010 — FORTRESS PEDICLE SCREW SYSTEM
- K133371 — RAMPART-L
- K132053 — RAMPART-O, RAMPART-T
- K131216 — RAMPART O
- K130396 — RAMPART O AND RAMPART P
- K123652 — SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
- K123232 — SPINEOLOGY SPINOUS PROCESS PLATE
- K121129 — SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
- K120293 — SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
- K113030 — SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
- K111880 — SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
- K110933 — SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
- K092464 — SPINEOLOGY FACET SCREW
- K033953 — OPTIMESH 500E CEMENT RESTRICTOR
- K014200 — OPTIMESH
- K002371 — K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
- K990959 — K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.