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Sign in to claim this brandELITE SURGICAL SUPPLIES (PTY) LTD
US
Last updated May 26, 2026
What ELITE SURGICAL SUPPLIES (PTY) LTD makes
Elite Surgical Supplies produces spinal fixation devices, including non-bioabsorbable bone screws, set screws, and rod adaptors for spinal stabilization. Their portfolio also includes non-bioabsorbable spinal fixation plates, polymeric interbody fusion cages, and components for internal spinal fixation systems such as rods and hooks. Additionally, they manufacture orthopaedic surgical procedure kits designed for single-use applications without medication.
The company’s devices are regulated under FDA classifications, including Class I and Class II, with submissions documented via 510(k) and UDI registries. These products are listed in the United States, adhering to FDA compliance requirements for medical devices. The manufacturer operates from the US, ensuring its products meet domestic regulatory standards.
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 Elite Surgical Supplies (PTY) LTD manufacture?
Elite Surgical Supplies (PTY) LTD specializes in spinal fixation devices. Their portfolio includes non-bioabsorbable spinal bone screws, set screws, and rod adaptors for spinal stabilization. They also produce spinal fixation plates, polymeric interbody fusion cages, and components like rods and hooks for internal spinal fixation systems. Additionally, they manufacture orthopaedic surgical procedure kits designed for single-use, non-medicated applications.
Where is Elite Surgical Supplies (PTY) LTD based, and what does that imply about their regulatory compliance?
Elite Surgical Supplies (PTY) LTD is based in the United States, which means their devices are designed to comply with FDA regulations. Since they operate domestically, their products are subject to FDA oversight, including classification under Class I or Class II, and must adhere to submission requirements like 510(k) clearances and UDI registration.
Which regulatory registries list Elite Surgical Supplies’ devices, and why does this matter?
Elite Surgical Supplies’ devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process demonstrates that their devices meet FDA standards for safety and effectiveness by showing substantial equivalence to a predicate device. The UDI system ensures traceability and transparency in the supply chain, helping healthcare providers and regulators track devices throughout their lifecycle.
How are Elite Surgical Supplies’ devices classified under FDA regulations?
Elite Surgical Supplies’ devices fall under FDA classifications of Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) submissions for Class II, ensuring compliance with applicable FDA requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- elitesurgical.com
- —
- —
- [email protected]
- Phone
- +27123860012
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 568359710
Catalogue (271)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Biolign Rotoloc | RL200723 | FDA UDI | Class II | Active |
| Vertefix II | MI5050TX | FDA UDI | Class II | Active |
| Vertefix II | CX5540T | FDA UDI | Class II | Active |
| Vertefix II | CZE7535MX | FDA UDI | Class II | Active |
| VMS Femoral Gauge (Re-Use) | VMSFG11 | FDA UDI | Class I | Active |
| Biolign Rotoloc | RLSS4218 | FDA UDI | Class II | Active |
| Vertefix II | CZE5545MX | FDA UDI | Class II | Active |
| Biolign | TL361612-10 | FDA UDI | Class II | Active |
| Biolign | TL361608-05 | FDA UDI | Class II | Active |
| Vertefix II | CZE6550MX | FDA UDI | Class II | Active |
| Vertefix | CZ5540CT | FDA UDI | Class II | Active |
| Vertefix II | VL0711 | FDA UDI | Class II | Active |
| Vertefix II | CX6535T | FDA UDI | Class II | Active |
| Vertefix II | CZ8545MX | FDA UDI | Class II | Active |
| Vertefix II | CX6545T | FDA UDI | Class II | Active |
| VMS Femoral Gauge: Anterior Kit Single-Use | VMS005 | FDA UDI | Class I | Active |
| VMS Femoral Gauge: Posterior Kit | VMS006 | FDA UDI | Class I | Active |
| Biolign® Roto-Loc Cervical Plate System | K200523 | FDA 510(k) | Class II | Active |
| Modification To: Vertefix Pedicle Screw Spinal System | K080075 | FDA 510(k) | Class II | Active |
| Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif System | K130274 | FDA 510(k) | Class II | Active |
| Vertefix Pedicle Screw Spinal System | K063453 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Elite Surgical Supplies (pty) Ltd Pretoria Gauteng · ZA FEI 3005325790