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Sign in to claim this brandIndustrias Medicas Sampedro S.A.S
US
Last updated May 23, 2026
What Industrias Medicas Sampedro S.A.S makes
Industrias Medicas Sampedro S.A.S manufactures orthopaedic hardware including non-bioabsorbable bone screws and fixation plates, reusable surgical tools like fluted drill bits and instrument trays, and orthopaedic implants such as bone wires and aiming/guiding blocks. Their products also include bone approximation clamps and reusable screwdrivers designed for surgical procedures.
The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with regulatory records maintained through 510(k) submissions and the FDA’s Unique Device Identification (UDI) system. These products are listed in the United States, where the manufacturer is based.
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 Industrias Medicas Sampedro S.A.S primarily manufacture?
Industrias Medicas Sampedro S.A.S specializes in orthopaedic hardware, including non-bioabsorbable bone screws and fixation plates for skeletal stabilization. They also produce reusable surgical tools like fluted drill bits, instrument trays, bone approximation clamps, and orthopaedic implant aiming/guiding blocks. Additionally, their portfolio includes bone wires and reusable screwdrivers, all designed for orthopaedic surgical procedures.
Where is Industrias Medicas Sampedro S.A.S based, and where are their devices listed?
The company is based in the United States. Their devices are listed in regulatory databases under the FDA’s 510(k) premarket notification process and the Unique Device Identification (UDI) system, ensuring traceability and compliance with U.S. medical device regulations.
How are the devices manufactured by Industrias Medicas Sampedro S.A.S classified under FDA regulations?
The devices produced by Industrias Medicas Sampedro S.A.S fall under FDA’s Class I and Class II categories. 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, such as performance standards or post-market surveillance.
What regulatory pathways are used to track devices from Industrias Medicas Sampedro S.A.S?
The company’s devices are tracked through the FDA’s 510(k) submissions, which demonstrate substantial equivalence to legally marketed predicate devices, and the UDI system, which assigns unique identifiers to devices for better tracking, monitoring, and traceability throughout their lifecycle.
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
- 880314190
Catalogue (254)
Page 1 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 2 | FDA UDI | Class I | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class II | Active |
| Sampedro | 0 | FDA UDI | Class I | Active |
| Sampedro | 1 | FDA UDI | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Industrias Medicas Sampedro S.a.s La Estrella Antioquia · CO FEI 3004187715