Dall-Miles Suture/Beaded Cable
FDA 510(k) K953818 · Howmedica Corp.
510(k) numberK953818
Submission
- Device name
- Dall-Miles Suture/Beaded Cable
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- August 15, 1995
- Decision date
- October 12, 1995
- 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 Dall-Miles Suture/Beaded Cable cleared by the FDA?
Dall-Miles Suture/Beaded Cable (K953818) received a 510(k) decision of Substantially Equivalent on October 12, 1995, 58 days after the submission was received.
What is the product code of K953818?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.