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Sign in to claim this brandPanther Orthopedics, Inc.
US
Last updated May 31, 2026
What Panther Orthopedics, Inc. makes
Panther Orthopedics, Inc. manufactures orthopaedic bone bolts, including the PUMA System, designed for internal fixation in bone surgery. These devices are intended for stabilizing fractures or performing arthrodesis procedures in skeletal applications.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. The manufacturer operates from 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 Panther Orthopedics, Inc. manufacture?
Panther Orthopedics, Inc. specializes in orthopaedic bone bolts, such as the PUMA System. These devices are primarily used for internal fixation in bone surgery, helping to stabilize fractures or facilitate arthrodesis (fusion of bones) in skeletal applications.
Where is Panther Orthopedics, Inc. based?
Panther Orthopedics, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution within the region.
How are Panther Orthopedics’ devices classified under FDA regulations?
Panther Orthopedics’ devices, including the PUMA System, are classified as Class II medical devices by the FDA. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as premarket notifications (510(k)) and compliance with UDI requirements.
Which regulatory registries or databases list Panther Orthopedics’ devices?
Panther Orthopedics’ devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices in compliance with U.S. regulatory standards.
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
- 117139687
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Puma System | GEN 3 | FDA UDI | Class II | Active |
| PUMA System | K171703 | FDA 510(k) | Class II | Active |
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