Dall Miles System Grooved Button
FDA 510(k) K934059 · Howmedica Corp.
510(k) numberK934059
Submission
- Device name
- Dall Miles System Grooved Button
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- August 19, 1993
- Decision date
- August 1, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 System Grooved Button cleared by the FDA?
Dall Miles System Grooved Button (K934059) received a 510(k) decision of Substantially Equivalent for Some Indications on August 1, 1994, 347 days after the submission was received.
What is the product code of K934059?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.