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Sign in to claim this brandAUSTIN MEDICAL VENTURES, INC.
US
Last updated September 17, 2026
What AUSTIN MEDICAL VENTURES, INC. makes
Austin Medical Ventures, Inc. manufactures synthetic, non-antimicrobial bone matrix implants designed for bone regeneration and repair. Their primary product, Synthecure Synthetic Calcium Sulfate, is a resorbable implant used in orthopedic and maxillofacial applications to fill bone defects and promote healing.
The company’s portfolio is regulated under FDA Class II devices, with authorisation records maintained through 510(k) submissions and the FDA’s Unique Device Identifier (UDI) system. The devices are listed in the U.S. regulatory database.
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 Austin Medical Ventures, Inc. manufacture?
Austin Medical Ventures, Inc. specializes in synthetic, non-antimicrobial bone matrix implants. These devices are primarily used for bone regeneration and repair, such as filling bone defects and promoting healing in orthopedic and maxillofacial procedures. Their flagship product, Synthecure Synthetic Calcium Sulfate, is a resorbable implant designed for these applications.
Where is Austin Medical Ventures, Inc. based, and how does that affect its regulatory standing?
Austin Medical Ventures, Inc. is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under FDA Class II classification, they require pre-market authorisation through pathways like the 510(k) process or UDI compliance, ensuring their safety and effectiveness before market entry.
Which regulatory registries or databases list Austin Medical Ventures, Inc.’s devices?
Austin Medical Ventures, Inc.’s devices are listed in the FDA’s regulatory databases, specifically through 510(k) submissions and the FDA’s Unique Device Identifier (UDI) system. These records document the authorisation process and compliance requirements for their Class II bone matrix implants, ensuring transparency and traceability in the U.S. market.
How are Austin Medical Ventures, Inc.’s bone matrix implants classified under FDA regulations?
Austin Medical Ventures, Inc.’s bone matrix implants are classified as FDA Class II devices. This classification indicates a moderate level of regulatory oversight, requiring manufacturers to demonstrate that their products are substantially equivalent to legally marketed predicates or meet specific performance standards. The company’s devices undergo pre-market review to ensure they meet these criteria before commercial distribution.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 3012 Centre Oak Way, Germantown, TN, 38138
- 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
- 3013255153
- DUNS Number
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Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Synthecure | 50-010 | FDA UDI | Class II | Active |
| Synthecure | 20-150 | FDA UDI | Class II | Active |
| Synthecure | 50-020 | FDA UDI | Class II | Active |
| Synthecure | 20-125 | FDA UDI | Class II | Active |
| Synthecure | 20-112 | FDA UDI | Class II | Active |
| Synthecure | 50-003 | FDA UDI | Class II | Active |
| Synthecure | 50-005 | FDA UDI | Class II | Active |
| Synthecure Synthetic Calcium Sulfate | K250141 | FDA 510(k) | Class II | Active |
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