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Dosimetry Release Of Radiation Steriliz
FDA 510(k)Class II (US FDA 510(k))
510(k) K831512
by Biomet, Inc.
Identifiers
- 510(k) Number
- K831512 FDA 510(k)
- FDA Product Code
- JDK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3300 FDA 510(k)
- Regulation Number
- 878.3300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DOSIMETRY RELEASE OF RADIATION STERILIZ is a medical device designed for the sterilization of orthopedic implants, such as hip and cement restrictors. This device is intended for use in plastic surgery procedures to ensure the sterility of implants before implantation.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831512 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K831512 24 fields · synced Jul 30, 2026