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Titan Spine, Inc.

US

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
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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Catalogue (5505)

Page 6 of 111
DeviceModel / ReferenceRegistriesClassStatus
Endoskeleton Tas 2312-9413
FDA UDI
Class IIUnknown
ENDOSKELETON® TL nanoLOCK® Surface Technology 7112-1109-N
FDA UDI
Class IIUnknown
ENDOSKELETON® TL Hyperlordotic 7224-1514
FDA UDI
Class IIUnknown
ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology 2320-0119-N
FDA UDI
Class IIUnknown
Endoskeleton Tl Retractor R14154-15
FDA UDI
Class IIUnknown
Endoskeleton® Ta 181-030-001
FDA UDI
Class IIActive
Endoskeleton TL 7107-0510
FDA UDI
Class IIUnknown
ENDOSKELETON® TCS Sterile Barrier System 5380-1605-S
FDA UDI
Class IIUnknown
ENDOSKELETON® TL nanoLOCK® Surface Technology 7112-1510-N
FDA UDI
Class IIUnknown
Endoskeleton® Tcs 5380-1607
FDA UDI
Class IIUnknown
ENDOSKELETON® TO nanoLOCK® Surface Technology 3114-2616-N
FDA UDI
Class IIUnknown
ENDOSKELETON® TC nanoLOCK® Surface Technology 5140-1208-N
FDA UDI
Class IIActive
Endoskeleton TL 7112-2513-S
FDA UDI
Class IIUnknown
ENDOSKELETON® TAS Sterile Barrier System 2302-1013-S
FDA UDI
Class IIUnknown
ENDOSKELETON Posterior DPK 1100-0015
FDA UDI
Class IUnknown
Endoskeleton TA 2107-0315-S
FDA UDI
Class IIUnknown
Endoskeleton® Tl 7107-2309
FDA UDI
Class IIUnknown
Endoskeleton® Tl 7300-1215
FDA UDI
Class IIUnknown
ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology 7130-1219-N
FDA UDI
Class IIUnknown
Endoskeleton TL 7107-1512-N
FDA UDI
Class IIUnknown
Endoskeleton Tas 2312-9415
FDA UDI
Class IIUnknown
ENDOSKELETON® TL Sterile Barrier System 7107-2110-S
FDA UDI
Class IIUnknown
ENDOSKELETON® TL Sterile Barrier System 7100-1310-S
FDA UDI
Class IIUnknown
Endoskeleton® Tl 7200-1097
FDA UDI
Class IIUnknown
Endoskeleton® Tl 845-030-101
FDA UDI
Class IIUnknown
Endoskeleton TCS 5340-1207-S
FDA UDI
Class IIUnknown
Endoskeleton® Tl 7100-2510
FDA UDI
Class IIUnknown
Endoskeleton TA 2107-0314
FDA UDI
Class IIUnknown
ENDOSKELETON® TL Sterile Barrier System 7100-1314-S
FDA UDI
Class IIUnknown
Endoskeleton® Tl 7112-1408
FDA UDI
Class IIUnknown
Endoskeleton TL 7107-2512-N
FDA UDI
Class IIUnknown
Endoskeleton Ta 2106-9313
FDA UDI
Class IIUnknown
Endoskeleton TL 7112-0509-N
FDA UDI
Class IIUnknown
Endoskeleton TC 5160-1412-S
FDA UDI
Class IIUnknown
Endoskeleton® Ta 181-041-001
FDA UDI
Class IIActive
Endoskeleton® Tl 7112-2516
FDA UDI
Class IIUnknown
Endoskeleton TCS 5301-3820
FDA UDI
Class IIUnknown
ENDOSKELETON® TL nanoLOCK® Surface Technology 7100-1115-N
FDA UDI
Class IIUnknown
Endoskeleton Tl Angled 7200-1067
FDA UDI
Class IUnknown
Endoskeleton TL 7112-0315-S
FDA UDI
Class IIUnknown
ENDOSKELETON® TL Hyperlordotic 7230-0520
FDA UDI
Class IIUnknown
Endoskeleton Dpk 831-1004-1
FDA UDI
Class IUnknown
Endoskeleton Tl 7300-1208
FDA UDI
Class IIUnknown
Endoskeleton TL 7107-1308
FDA UDI
Class IIUnknown
ENDOSKELETON® Sterile Barrier System 1130-1030
FDA UDI
Class IIUnknown
Endoskeleton Tas 2300-1034
FDA UDI
Class IIUnknown
ENDOSKELETON® TL Hyperlordotic 7224-1518
FDA UDI
Class IIUnknown
ENDOSKELETON® TL nanoLOCK® Surface Technology 7112-1113-N
FDA UDI
Class IIUnknown
ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology 2324-0119-N
FDA UDI
Class IIUnknown
ENDOSKELETON® TCS Sterile Barrier System 5340-1211-S
FDA UDI
Class IIUnknown

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.

DateRecall No.ClassStatusReason
Jul 20, 2015Z-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, 2015Z-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, 2012Z-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.