Tantalum Beads - Radiographic Marker
FDA 510(k) K010348 · Biomet, Inc.
510(k) numberK010348
Submission
- Device name
- Tantalum Beads - Radiographic Marker
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- February 5, 2001
- Decision date
- May 3, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Tantalum Beads - Radiographic Marker cleared by the FDA?
Tantalum Beads - Radiographic Marker (K010348) received a 510(k) decision of Substantially Equivalent on May 3, 2001, 87 days after the submission was received.
What is the product code of K010348?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.