89 results
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53ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·May 6, 2015
ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·March 27, 2013
ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code KWP·July 6, 2011
4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code KWQ·April 10, 2015
Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology.
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code MAX·May 13, 2009
Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021