BMP Cable System
FDA 510(k) K982545 · Biomet, Inc.
510(k) numberK982545
Submission
- Device name
- BMP Cable System
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- July 21, 1998
- Decision date
- October 19, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was BMP Cable System cleared by the FDA?
BMP Cable System (K982545) received a 510(k) decision of Substantially Equivalent on October 19, 1998, 90 days after the submission was received.
What is the product code of K982545?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.