Is this your brand? Sign in to claim ownership.
Sign in to claim this brandTitan 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
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (5505)
Page 3 of 111| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Endoskeleton Ta | 2106-7214 | FDA UDI | Class II | Unknown |
| Endoskeleton TO | 3114-2213-N | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7100-0512 | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7100-1514-N | FDA UDI | Class II | Unknown |
| Endoskeleton TA | 2107-0215-S | FDA UDI | Class II | Unknown |
| Endoskeleton Tcs | 5086-1611 | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7100-1312-S | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7112-0211-S | FDA UDI | Class II | Unknown |
| Endoskeleton TAS | 2312-0317-S | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7100-0209-N | FDA UDI | Class II | Unknown |
| Endoskeleton TA | 2107-0110 | FDA UDI | Class II | Unknown |
| Endoskeleton Tl | 7900-1004 | FDA UDI | Class II | Unknown |
| Endoskeleton TT | 4110-3014-N | FDA UDI | Class II | Unknown |
| Endoskeleton Tcs | 5046-1207 | FDA UDI | Class II | Unknown |
| Endoskeleton® Tl | 7107-2415 | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7107-0214-S | FDA UDI | Class II | Unknown |
| Endoskeleton® Dpk | 1900-0012 | FDA UDI | Class II | Unknown |
| ENDOSKELETON® TAS Sterile Barrier System | 2312-0112-S | FDA UDI | Class II | Unknown |
| Endoskeleton TCS | 5386-1608-N | FDA UDI | Class II | Unknown |
| ENDOSKELETON® TO Sterile Barrier System | 3110-2208-S | FDA UDI | Class II | Unknown |
| Endoskeleton® Tl | 7207-2510 | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7107-0308-S | FDA UDI | Class II | Unknown |
| Endoskeleton TCS | 5301-3816 | FDA UDI | Class II | Unknown |
| ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology | 2316-0119-N | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7107-2115 | FDA UDI | Class II | Unknown |
| Endoskeleton TC | 5146-1205 | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7107-2213 | FDA UDI | Class II | Unknown |
| Endoskeleton® Tcs | 5380-1609 | FDA UDI | Class II | Unknown |
| Endoskeleton® Tt | 4900-1020 | FDA UDI | Class II | Unknown |
| Endoskeleton® Tas | 2312-1114 | FDA UDI | Class II | Unknown |
| ENDOSKELETON® TO Sterile Barrier System | 3110-3108-S | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7100-2408 | FDA UDI | Class II | Unknown |
| Endoskeleton® Tl | 7112-0216 | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7112-0409-N | FDA UDI | Class II | Unknown |
| ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology | 7130-1118-N | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7100-1215-S | FDA UDI | Class II | Unknown |
| ENDOSKELETON® TL nanoLOCK® Surface Technology | 7112-1515-N | FDA UDI | Class II | Unknown |
| ENDOSKELETON® TL nanoLOCK® Surface Technology | 7107-2116-N | FDA UDI | Class II | Unknown |
| Endoskeleton® Tcs | 5380-1611 | FDA UDI | Class II | Unknown |
| Endoskeleton® Tas | 2312-1111 | FDA UDI | Class II | Active |
| Endoskeleton TL | 7112-0510-S | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7100-2214 | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7112-1314-N | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7112-2311-N | FDA UDI | Class II | Unknown |
| Endoskeleton TL | 7100-0316-S | FDA UDI | Class II | Unknown |
| ENDOSKELETON® TL Sterile Barrier System | 7112-0310-S | FDA UDI | Class II | Unknown |
| ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology | 7116-1317-N | FDA UDI | Class II | Unknown |
| Endoskeleton TO | 3114-3112 | FDA UDI | Class II | Unknown |
| Endoskeleton TC | 5166-1409-N | FDA UDI | Class II | Unknown |
| ENDOSKELETON® TAS Hyperlordotic Sterile Barrier System | 2316-0212-S | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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. |