Dall-Miles Cable Grip (A-Grip)
FDA 510(k) K984432 · Howmedica Osteonics Corp.
510(k) numberK984432
Submission
- Device name
- Dall-Miles Cable Grip (A-Grip)
- Applicant
- Howmedica Osteonics Corp.
Rutherford, NJ, US - Received
- December 14, 1998
- Decision date
- February 24, 1999
- 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 Cable Grip (A-Grip) cleared by the FDA?
Dall-Miles Cable Grip (A-Grip) (K984432) received a 510(k) decision of Substantially Equivalent on February 24, 1999, 72 days after the submission was received.
What is the product code of K984432?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.