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Alphatec Spine, Inc.

Manufacturer
🇺🇸 United States

Alphatec Spine, Inc.

FDA registration
Alphatec Spine, Inc.·74 products·🇺🇸 United States

ALPHATEC SPINE, INC.

FDA registration
ALPHATEC SPINE, INC.·74 products·🇺🇸 United States

ALPHATEC SPINE, INC.

FDA registration
ALPHATEC SPINE, INC.·3 products·🇺🇸 United States

ZODIAC PEDICLE SCREW SYSTEM

FDA Adverse Event
Malfunction ·ALPHATEC SPINE, INC.·Product code MNI·February 12, 2008

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

TRESTLE

FDA Adverse Event
Malfunction ·ALPHATEC SPINE, INC.·Product code KWQ·April 18, 2008

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