Spinefrontier, Inc.
Spinefrontier, Inc. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2020, with 33 FDA device recalls on record.
Top product codes for Spinefrontier, Inc.
FDA recalls by Spinefrontier, Inc.
10 most recent of 33- Z-1973-2019 — A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
- Z-1479-2015 — SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
- Z-0977-2015 — lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
- Z-0555-2014 — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
- Z-0576-2014 — Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
- Z-0574-2014 — Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
- Z-0554-2014 — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
- Z-0575-2014 — Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
- Z-0573-2014 — Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.
- Z-0553-2014 — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
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 Spinefrontier, Inc.
- K193106 — SpineFrontier Lumbar Interbody Fusion Device System
- K172484 — A-CIFT SoloFuse
- K151198 — A-CIFT SoloFuse
- K142504 — SpineFrontier Lumbar Interbody Fusion Device System
- K150017 — SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
- K143377 — PedFuse Pedicle Screw System
- K141333 — ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
- K142026 — SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
- K141337 — ARENA-C
- K133153 — SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
- K131880 — SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM
- K132740 — SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
- K123164 — SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
- K121060 — SPINE FRONTIER INDUS ACP SYSTEM
- K113518 — ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
- K111553 — SPINEFRONTIER LUMBAR IBF SYSTEM
- K102020 — VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
- K092815 — S-LIF INTERVERTEBRAL BODY FUSION DEVICE
- K093776 — INDUS ANTERIOR CERVICAL PLATE SYSTEM
- K092420 — KRD1 PEDICLE SCREW SYSTEM
- K091638 — DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
- K073232 — INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX
- K071420 — CHAMELEON FIXATION SYSTEM
- K072289 — SPINEFRONTIER DORADO VBR
Data sourced from openFDA. This site is unofficial and independent of the FDA.