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Sign in to claim this brandMEDITECH SPINE, LLC
US
Last updated May 23, 2026
What MEDITECH SPINE, LLC makes
Meditech Spine, LLC manufactures polymeric spinal fusion cages designed for interbody fusion, including both sterile and trial versions, as well as reusable sizer holders for spinal implants. Their portfolio includes non-bioabsorbable spinal fixation plates, screws, and orthopaedic fixation system implantation kits. They also produce fluted surgical drill bits for spinal procedures.
All listed devices fall under FDA Class II regulation and are recorded in the FDA’s Unique Device Identification (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 Meditech Spine, LLC primarily manufacture?
Meditech Spine, LLC specializes in spinal implants and related devices. Their portfolio includes polymeric spinal fusion cages (both sterile and trial versions), reusable sizer holders for spinal implants, non-bioabsorbable spinal fixation plates and screws, orthopaedic fixation system implantation kits, and fluted surgical drill bits for spinal procedures. These devices are designed for spinal fusion, stabilization, and surgical preparation.
Where is Meditech Spine, LLC based, and what does this mean for regulatory oversight?
Meditech Spine, LLC is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies all of Meditech Spine’s listed devices as Class II, which typically requires premarket notification (510(k)) clearance before commercial distribution, ensuring they meet performance and safety standards for their intended use.
Are Meditech Spine, LLC’s devices listed in any regulatory registries, and why does this matter?
Yes, Meditech Spine’s devices are recorded in the FDA’s Unique Device Identification (UDI) database. This registry tracks device details like manufacturer information, model names (e.g., TALOS®-C or CURE LP), and regulatory status. Including devices in the UDI system improves transparency, helps healthcare providers verify product authenticity, and supports post-market surveillance efforts.
How are Meditech Spine’s devices classified by the FDA, and what does this classification imply?
The FDA classifies all of Meditech Spine’s listed devices as Class II. This classification indicates moderate risk, requiring manufacturers to demonstrate that their devices are substantially equivalent to legally marketed predicate devices through a 510(k) submission. Class II devices undergo additional scrutiny to ensure they perform as intended without posing unreasonable risks to patients.
What distinguishes Meditech Spine’s spinal fusion cages from other similar devices in the market?
Meditech Spine’s spinal fusion cages are primarily made from polymeric materials, which are designed to provide structural support during spinal fusion procedures. The company offers both sterile and trial versions, allowing surgeons to test fit and stability before final implantation. Their cages are part of a broader system that may include fixation plates, screws, and reusable sizers, ensuring compatibility with other components in spinal stabilization surgeries.
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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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 182698477
Catalogue (5370)
Page 80 of 108| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Talos® Ibf | 100-1109-30 | FDA UDI | Class II | Active |
| Talos® (ha) Ibf | 613-271315-00 | FDA UDI | Class II | Active |
| Talos® (ha) Ibf | 613-270115-15 | FDA UDI | Class II | Active |
| Cure™ Acp | S1-7-00002-38 | FDA UDI | Class II | Active |
| Talos° Ha Peek Ibf | 6-220208-00 | FDA UDI | Class II | Active |
| Talos®-C | 509-313310-14 | FDA UDI | Class II | Active |
| Talos° Ha Peek Ibf | 6-221314-15 | FDA UDI | Class II | Active |
| Talos® Ibf | 3-11116-06 | FDA UDI | Class II | Active |
| Talos® Ibf | 3-11215-25 | FDA UDI | Class II | Active |
| Talos® Ha Peek Ibf | 3-22114-11 | FDA UDI | Class II | Active |
| Talos° Ha Peek Ibf | 6-221014-00 | FDA UDI | Class II | Active |
| Talos° Ha Peek Ibf | 3-21310-25 | FDA UDI | Class II | Active |
| Cure Lp | 900-462-00 | FDA UDI | Class II | Active |
| Talos® Ibf | 3-12510-11 | FDA UDI | Class II | Active |
| Talos® Ibf | 4-082640 | FDA UDI | Class II | Active |
| Cure Lp | S1-9-42460-50 | FDA UDI | Class II | Active |
| Talos® (ha) Ibf | 613-270313-00 | FDA UDI | Class II | Active |
| Talos®-C | 5-061212-00-A | FDA UDI | Class II | Active |
| Cure Opel-C | 11-0T001-30 | FDA UDI | Class II | Active |
| Talos® Ibf | 4-102660-06 | FDA UDI | Class II | Active |
| Talos® Ibf | 4-182250 | FDA UDI | Class II | Active |
| Talos® Ibf | 4-112030-06 | FDA UDI | Class II | Active |
| Cure™ Acp | 7-00002-30 | FDA UDI | Class II | Active |
| Talos® Ibf | 4-082655-06 | FDA UDI | Class II | Active |
| Cure Lp | 9-00061-37 | FDA UDI | Class II | Active |
| Talos®-C Ha | 5-21605-07 | FDA UDI | Class II | Active |
| Talos° Ha Peek Ibf | 6-220418-00 | FDA UDI | Class II | Active |
| Talos® (ha) Ibf | 613-271611-00 | FDA UDI | Class II | Active |
| Talos® Ibf | 4-092450-06 | FDA UDI | Class II | Active |
| Talos®-C | 515-120200 | FDA UDI | Class II | Active |
| Talos® Ibf | 3-11217-12 | FDA UDI | Class II | Active |
| Talos®-C | 500-111614-00-A | FDA UDI | Class II | Active |
| Talos® (ha) Ibf | 613-271707-15 | FDA UDI | Class II | Active |
| Talos® (ha) Ibf | 613-270415-00 | FDA UDI | Class II | Active |
| Cure™ Acp | T-7-40044-70 | FDA UDI | Class II | Active |
| Talos® (ha) Ibf | 613-271317-07 | FDA UDI | Class II | Active |
| Talos®-C | 500-071212-00 | FDA UDI | Class II | Active |
| Talos®-C | 500-081815-07 | FDA UDI | Class II | Active |
| Talos® (ha) Ibf | 613-271711-07 | FDA UDI | Class II | Active |
| Talos® Ibf | 4-132445 | FDA UDI | Class II | Active |
| Talos®-C | 5-062014-00-A | FDA UDI | Class II | Active |
| Talos®-C | 5-101812-00-A | FDA UDI | Class II | Active |
| Talos° Ha Peek Ibf | 6-220218-00 | FDA UDI | Class II | Active |
| Cure™ Acp | T-7-40042-37 | FDA UDI | Class II | Active |
| Talos® Ibf | 310-123320-16 | FDA UDI | Class II | Active |
| Talos®-C Ha | 5-22007-07 | FDA UDI | Class II | Active |
| Talos® Ibf | 4-162240 | FDA UDI | Class II | Active |
| Talos® (ha) Ibf | 613-271419-00 | FDA UDI | Class II | Active |
| Talos®-C Ha | 5-22306-00 | FDA UDI | Class II | Active |
| Talos®-C | 5-081614-00 | FDA UDI | Class II | Active |
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