The New Bio-Moore Endo Heads
FDA 510(k) K984028 · Biomet, Inc.
510(k) numberK984028
Submission
- Device name
- The New Bio-Moore Endo Heads
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- November 12, 1998
- Decision date
- January 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was The New Bio-Moore Endo Heads cleared by the FDA?
The New Bio-Moore Endo Heads (K984028) received a 510(k) decision of Substantially Equivalent on January 19, 1999, 68 days after the submission was received.
What is the product code of K984028?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.