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Titan Spine, Inc.

Last updated May 23, 2026

What Titan Spine, Inc. makes

The company manufactures metallic spinal interbody fusion cages designed for intervertebral support, including models with hyperlordotic and nanoLOCK® surface technologies. It also produces reusable orthopaedic instruments such as spinal bone screws, bone curettes, bone levers/elevators, rongeurs, and implant inserter/extractors, alongside spinal implant trials for preoperative planning.

These devices are regulated under FDA classifications, including Class I and Class II, with submissions recorded in the FDA’s 510(k) and UDI registries. 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 Titan Spine, Inc. manufacture?

Titan Spine, Inc. specializes in metallic spinal interbody fusion cages, which are used to provide support and stability between vertebrae. Their product line also includes reusable orthopaedic instruments like spinal bone screws, bone curettes, bone levers/elevators, rongeurs, and implant inserter/extractors. Additionally, they produce spinal implant trials, which help in preoperative planning to ensure proper device fit and positioning.

Where is Titan Spine, Inc. based?

Titan Spine, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA).

Which regulatory registries list Titan Spine, Inc.’s devices?

Titan Spine, Inc.’s devices are recorded in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track submissions and classifications required for compliance with U.S. medical device regulations.

How are Titan Spine, Inc.’s devices classified under FDA regulations?

Titan Spine, Inc.’s devices are classified under FDA categories, including Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s purpose, intended use, and potential risks.

What distinguishes Titan Spine, Inc.’s spinal interbody fusion cages from other similar products?

Titan Spine, Inc.’s spinal interbody fusion cages include specialized designs like hyperlordotic models, which are tailored to restore or maintain the natural curvature of the spine. Some models feature nanoLOCK® Surface Technology, a proprietary surface treatment intended to enhance stability and integration with bone. These innovations address specific clinical needs, such as improving fusion rates or reducing slippage during healing.

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

Information

Country: US
Address: —
Website: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (5505)

Page 4 of 111

Device	Model / Reference	Registries	Class	Status
Endoskeleton TC	5140-1210-N	FDA UDI	Class II	Unknown
ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology	7120-2320-N	FDA UDI	Class II	Unknown
Endoskeleton Tas	2300-1039	FDA UDI	Class II	Unknown
Endoskeleton TT	4110-3014	FDA UDI	Class II	Unknown
ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology	7130-0116-N	FDA UDI	Class II	Unknown
Endoskeleton Tas	2307-9009	FDA UDI	Class II	Unknown
Endoskeleton TL	7107-1208-S	FDA UDI	Class II	Unknown
ENDOSKELETON® TCS Sterile Barrier System	5360-1409-S	FDA UDI	Class II	Unknown
Endoskeleton® Tl	7200-1148	FDA UDI	Class II	Unknown
ENDOSKELETON® TL nanoLOCK® Surface Technology	7112-2414-N	FDA UDI	Class II	Unknown
ENDOSKELETON® TL nanoLOCK® Surface Technology	7100-0315-N	FDA UDI	Class II	Unknown
ENDOSKELETON® TAS Sterile Barrier System	2307-0112-S	FDA UDI	Class II	Unknown
Endoskeleton Tas	2300-1101	FDA UDI	Class II	Unknown
Endoskeleton TL	7107-2213-N	FDA UDI	Class II	Unknown
ENDOSKELETON® TL nanoLOCK® Surface Technology	7112-0408-N	FDA UDI	Class II	Unknown
Endoskeleton TL	7107-0214-N	FDA UDI	Class II	Unknown
ENDOSKELETON® TL Sterile Barrier System	7100-0311-S	FDA UDI	Class II	Unknown
Endoskeleton TAS	2307-0216	FDA UDI	Class II	Unknown
Endoskeleton Ta	2112-7313	FDA UDI	Class II	Unknown
Endoskeleton TL	7112-2110-S	FDA UDI	Class II	Unknown
Endoskeleton Tl	7200-1122	FDA UDI	Class II	Unknown
ENDOSKELETON® TC Sterile Barrier System	5160-1412-S	FDA UDI	Class II	Unknown
Endoskeleton Dpk	PI-1742	FDA UDI	Class I	Unknown
ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology	7116-2119-N	FDA UDI	Class II	Unknown
ENDOSKELETON® TL Hyperlordotic	7230-2519	FDA UDI	Class II	Unknown
ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology	7116-2418-N	FDA UDI	Class II	Unknown
ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology	7130-0117-N	FDA UDI	Class II	Unknown
Endoskeleton TT	4110-3008-N	FDA UDI	Class II	Unknown
ENDOSKELETON® TAS Hyperlordotic Sterile Barrier System	2316-0113-S	FDA UDI	Class II	Unknown
ENDOSKELETON® TCS Sterile Barrier System	5380-1610-S	FDA UDI	Class II	Unknown
ENDOSKELETON® TL nanoLOCK® Surface Technology	7100-2413-N	FDA UDI	Class II	Unknown
ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology	7116-0413-N	FDA UDI	Class II	Unknown
ENDOSKELETON® TCS Sterile Barrier System	5386-1609-S	FDA UDI	Class II	Unknown
Endoskeleton® Tl	7200-1512	FDA UDI	Class II	Unknown
ENDOSKELETON® TCS Sterile Barrier System	5301-3520-S	FDA UDI	Class II	Unknown
ENDOSKELETON® TL nanoLOCK® Surface Technology	7100-1411-N	FDA UDI	Class II	Unknown
Endoskeleton TL	7112-1509-S	FDA UDI	Class II	Unknown
Endoskeleton® Tcs	5210-1005	FDA UDI	Class II	Unknown
Endoskeleton TL	7107-1216	FDA UDI	Class II	Unknown
ENDOSKELETON® TL Sterile Barrier System	7112-1408-S	FDA UDI	Class II	Unknown
ENDOSKELETON® TC nanoLOCK® Surface Technology	5140-1209-N	FDA UDI	Class II	Active
Endoskeleton® Tcs	5210-1029	FDA UDI	Class II	Unknown
Endoskeleton TL	7100-0310-N	FDA UDI	Class II	Unknown
Endoskeleton® Tl	7200-2515	FDA UDI	Class II	Unknown
Endoskeleton TCS	5301-3517	FDA UDI	Class II	Unknown
Endoskeleton TL	7112-1511-S	FDA UDI	Class II	Unknown
Endoskeleton® Tcs	5340-1205	FDA UDI	Class II	Unknown
ENDOSKELETON® TAS Sterile Barrier System	2312-0117-S	FDA UDI	Class II	Unknown
ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology	7124-2218-N	FDA UDI	Class II	Unknown
Endoskeleton TL	7100-1311-S	FDA UDI	Class II	Unknown

Related Companies

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FDA Recalls (3)

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

Titan Spine, Inc. has three recall records initiated between October 19, 2012, and July 20, 2015, all of which are recorded as terminated. The recalls involved incorrect labeling for Endoskeleton TA VBR products, non-locking collars on specific Endoskeleton TCS Integrated Locking Bone Screw Assemblies, and a malfunction where the tip of TCS Straight Hexlobular #6 Drivers (Lot# G150101) sheared off during use in dense bone procedures.

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
Jul 20, 2015	Z-2327-2015	—	terminated	Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
Feb 20, 2015	Z-1324-2015	—	terminated	The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drivers (5210-1004) Lot# G150101 from the field.
Oct 19, 2012	Z-0535-2013	—	terminated	Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.