RC Buttress
FDA 510(k) K991009 · Biomet, Inc.
510(k) numberK991009
Submission
- Device name
- RC Buttress
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- March 26, 1999
- Decision date
- June 23, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was RC Buttress cleared by the FDA?
RC Buttress (K991009) received a 510(k) decision of Substantially Equivalent on June 23, 1999, 89 days after the submission was received.
What is the product code of K991009?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.