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ALPHATEC SPINE, INC.

Last updated September 17, 2026

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 16 of 500

Device	Model / Reference	Registries	Class	Status
Invictus	19020-50-38	FDA UDI	Class II	Active
Novel	CI-10201-10	FDA UDI	Class I	Active
ATEC Biologics	67117-109	FDA UDI	Class I	Active
Arsenal	47200-070-115	FDA UDI	Class II	Active
General Instruments	CI-10610-02	FDA UDI	Class I	Active
Arsenal Deformity Spinal Fixation System	48700-020-070-035	FDA UDI	Class II	Active
Invictus	15055-125-100	FDA UDI	Class II	Active
Invictus	15013-060-050	FDA UDI	Class II	Active
Intervertebral Disc Preparation Instruments	240-11-100-08	FDA UDI	Class I	Active
IdentiTi	255-10-14227010	FDA UDI	Class II	Active
IdentiTi	255-12-11186005	FDA UDI	Class II	Active
IdentiTi	134-11181600-S	FDA UDI	Class II	Active
Arsenal	48500-100-095	FDA UDI	Class II	Active
Invictus	18000-45-22	FDA UDI	Class II	Active
IdentiTi	100-11164500-S	FDA UDI	Class II	Active
Novel Spinal Spacer System	64333-130	FDA UDI	Class II	Active
Novel Spinal Spacer System	64313-420	FDA UDI	Class II	Active
IdentiTi	135-6100-05	FDA UDI	Class II	Active
Identiti	100-06225515-S	FDA UDI	Class II	Active
Arsenal	47210-065-080	FDA UDI	Class II	Active
Invictus	11002-040-055	FDA UDI	Class II	Active
Invictus	19008-40-26	FDA UDI	Class II	Active
Invictus	55203-060-070	FDA UDI	Class II	Active
General Instruments	PTPARM	FDA UDI	Class I	Active
Invictus	18000-40-34	FDA UDI	Class II	Active
Arsenal	47210-070-050	FDA UDI	Class II	Active
Arsenal	47420-065-100	FDA UDI	Class II	Active
Illico	73779	FDA UDI	Class I	Active
Battalion	27438-101-1816	FDA UDI	Class II	Active
Battalion	27438-100-2009	FDA UDI	Class II	Active
Invictus	16187-26-90	FDA UDI	Class I	Active
IdentiTi	255-10-11187010	FDA UDI	Class II	Active
Transcend NanoTec	144-PRO-09102510-S	FDA UDI	Class II	Active
Valence Robotic Navigation System	525-422	FDA UDI	Class II	Active
Invictus OsseoScrew	16196-050	FDA UDI	Class II	Active
IdentiTi	334-12181505-S	FDA UDI	Class II	Active
Segmental Plating System	338-1-13516	FDA UDI	Class II	Active
Invictus	55225-105-050	FDA UDI	Class II	Active
IDENTITi NANOTEC	100-PRO-14225010-S	FDA UDI	Class II	Active
IDENTITi NANOTEC	100-PRO-12186525-S	FDA UDI	Class II	Active
IdentiTi	134-2-40-13	FDA UDI	Class II	Active
IdentiTi	127-10-05141205	FDA UDI	Class II	Active
Invictus	15225-60-300	FDA UDI	Class II	Active
Arsenal	47210-105-060	FDA UDI	Class II	Active
Arsenal	48700-000-085-110	FDA UDI	Class II	Active
Ascend	158-210	FDA UDI	Class I	Active
Osteotomy Instruments	152-01-100-28	FDA UDI	Class I	Active
Segmental Plating System	338-1-44017	FDA UDI	Class II	Active
Invictus	11501-125	FDA UDI	Class II	Active
Invictus	15023-065-095	FDA UDI	Class II	Active

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Importers

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Notified Bodies

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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.

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.