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ALPHATEC SPINE, INC.

Last updated September 17, 2026

What ALPHATEC SPINE, INC. makes

Alphatec Spine manufactures spinal fixation hardware, including non-bioabsorbable bone screws, metallic and polymeric interbody fusion cages, and vertebral body prostheses. Their portfolio also includes reusable bone levers/elevators, spinal fixation plates, and internal fixation rod systems for surgical stabilization. Trial implants for spinal procedures and modular systems like the IdentiTi, AMP, Invictus, Calibrate, and Battalion are part of their product line.

These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Alphatec Spine, Inc. primarily manufacture?

Alphatec Spine, Inc. specializes in spinal fixation devices, including non-bioabsorbable bone screws, metallic and polymeric interbody fusion cages, and vertebral body prostheses. Their product line also covers reusable surgical tools like bone levers/elevators, spinal fixation plates, and internal fixation rod systems. These devices are designed to support spinal stabilization and fusion procedures.

Where is Alphatec Spine, Inc. based, and how does that affect its regulatory standing?

Alphatec Spine, Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s Class I and Class II categories. This classification determines the regulatory pathway for authorization, such as 510(k) clearance for Class II devices.

Which regulatory registries or databases list Alphatec Spine’s devices?

Alphatec Spine’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and transparency in the medical device supply chain, helping regulators, healthcare providers, and patients track specific devices like their spinal implants, screws, and fusion cages.

How are Alphatec Spine’s devices classified under FDA regulations?

Alphatec Spine’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and typically require premarket notification (510(k)) clearance to demonstrate substantial equivalence to a predicate device. The classification depends on factors like device purpose, surgical invasiveness, and potential patient risk.

Does Alphatec Spine offer modular or trial implants for spinal procedures?

Yes, Alphatec Spine includes modular systems and trial implants in its portfolio. For example, their IdentiTi, AMP, Invictus, Calibrate, and Battalion products are designed to provide flexibility in surgical planning, allowing for customization or temporary implantation to assess outcomes before permanent fixation. These trial implants help surgeons evaluate stability and fit during spinal procedures.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 1950 Camino Vida Roble, Carlsbad, CA, 92008
Website: alphatecspine.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(760)431-9286
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2027467
DUNS Number: 602465783

Catalogue (44610)

Page 38 of 500

Device	Model / Reference	Registries	Class	Status
Arsenal	47210-105-105	FDA UDI	Class II	Active
Battalion	27221-14	FDA UDI	Class I	Active
Zodiac	62755-60	FDA UDI	Class II	Active
IDENTITi NANOTEC	100-PRO-11224030-S	FDA UDI	Class II	Active
Invictus	17401-01-T	FDA UDI	Class I	Active
IDENTITi NANOTEC	100-PRO-08186020-S	FDA UDI	Class II	Active
Invictus	15703-050-025	FDA UDI	Class II	Active
Invictus	55203-065-090	FDA UDI	Class II	Active
IdentiTi	132-13382815-S	FDA UDI	Class II	Active
Invictus	18807-40	FDA UDI	Class I	Active
Invictus	19837-35	FDA UDI	Class I	Active
Battalion	27024-1315-S	FDA UDI	Class II	Active
Invictus	15013-070-065	FDA UDI	Class II	Active
General Instruments	CI-11810	FDA UDI	Class I	Active
General Instruments	CI-11763-20	FDA UDI	Class I	Active
General Instruments	CI-11343-635	FDA UDI	Class I	Active
General Instruments	CI-11736-07	FDA UDI	Class I	Active
Battalion	27013-021-S	FDA UDI	Class II	Active
Novel	CI-10386-10-09141207	FDA UDI	Class II	Active
General Instruments	CI-11375-02-L	FDA UDI	Class I	Active
General Instruments	CI-10615	FDA UDI	Class I	Active
Battalion	27438-101-2015	FDA UDI	Class II	Active
Core Lumbar Fixation System	81385-340	FDA UDI	Class II	Active
Battalion	27438-103-2408	FDA UDI	Class II	Active
Invictus	18030-40-56	FDA UDI	Class II	Active
IdentiTi II	800-08185010-S	FDA UDI	Class II	Active
Transcend NanoTec	310-PRO-08141210-S	FDA UDI	Class II	Active
Invictus	15055-110-030	FDA UDI	Class II	Active
Invictus	15011-055-065	FDA UDI	Class II	Active
ATEC Porous Ti Interbody System	115-06201812	FDA UDI	Class II	Active
Calibrate	326-PRO-09102215-S	FDA UDI	Class II	Active
Invictus	55203-050-045	FDA UDI	Class II	Active
Arsenal	48800-100-050	FDA UDI	Class II	Active
Arsenal	48200-070-105	FDA UDI	Class II	Active
General Instruments	CI-10698	FDA UDI	Class I	Active
General Instruments	CI-11839-16	FDA UDI	Class I	Active
General Instruments	CI-11642-120-100	FDA UDI	Class I	Active
General Instruments	CI-11391-12	FDA UDI	Class I	Active
Solanas	63010	FDA UDI	Class II	Active
Zodiac	62765-40	FDA UDI	Class II	Active
Zodiac	82006-20	FDA UDI	Class II	Active
Arsenal	48100-040-050	FDA UDI	Class II	Active
Ascend	157-PRO-16B-183000-S	FDA UDI	Class II	Active
IdentiTi NanoTec	124-PRO-09102515-S	FDA UDI	Class II	Active
Ascend	157-PRO-16L-183005-S	FDA UDI	Class II	Active
Invictus	17829-200	FDA UDI	Class I	Active
Invictus	11004-065-060	FDA UDI	Class II	Active
Invictus	15502-055	FDA UDI	Class II	Active
Arsenal	87759-070	FDA UDI	Class I	Active
Invictus	55203-065-115	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Authorities

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FDA Recalls (19)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Alphatec Spine, Inc. has 19 recall records initiated between August 16, 2007, and April 10, 2015, all of which are marked as terminated. The recalls were primarily due to manufacturing errors, including incorrect labeling, laser marking, and dimensional inaccuracies, such as wrong part numbers, sizes, and lengths. Additional issues involved misalignment, improper angulation, and functional defects in components like screws, rods, and wrenches, as well as durability concerns with certain instruments.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 10, 2015	Z-1547-2015	—	terminated	During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a result the firm recalling the affected lots codes for this mislabeling.
Jun 26, 2014	Z-2092-2014	—	terminated	Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use.
Jun 28, 2013	Z-2086-2013	—	terminated	The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver.
May 6, 2013	Z-1421-2013	—	terminated	Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adve
Sep 25, 2012	Z-0168-2013	—	terminated	The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering such screws nonfunctional.
May 29, 2012	Z-2273-2012	—	terminated	On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on the Trestle Luxe Plate.
Mar 19, 2012	Z-1676-2012	—	terminated	Alphatec Spine has received several complaints (n+4) on the Alphatec Solus Distal Deployment Wrench for twisting or bending, which has been discovered either during or after instrumentation use. A fifth complaint received in which it was reported that the spline tip of the Alphatec Solus Proximal Deployment Wrench had sheared from the instrument upon use.
Jul 6, 2011	Z-0967-2013	—	terminated	The rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.
Dec 9, 2010	Z-0269-2013	—	terminated	The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.
Nov 1, 2010	Z-0932-2012	—	terminated	These lots were not manufactured correctly in that the instrument does not have the durability required to repeatedly perform over its full service life and, therefore, may experience breakage in the tips.
Aug 25, 2009	Z-1746-2010	—	terminated	The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds to a two-level Trestle Anterior Cervical Plate implant.
Aug 5, 2009	Z-0503-2010	—	terminated	Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.
Aug 5, 2009	Z-0502-2010	—	terminated	Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.
May 13, 2009	Z-0190-2010	—	terminated	Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.
Jan 28, 2009	Z-0498-2010	—	terminated	The recall was initiated after Alphatec Spine received a complaint on the ILLICO Posterior Thoracolumbar access retractor. It was reported that one of the retractor arms in the retractor broke during surgery.
Dec 16, 2008	Z-0036-2010	—	terminated	Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of the caddy. The actual ROC bolts themselves are correctly laser etched.
Nov 3, 2008	Z-0491-2010	—	terminated	Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x 50 mm L.
Aug 16, 2007	Z-0508-2009	—	terminated	Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.
Aug 16, 2007	Z-0507-2009	—	terminated	Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.