Dall Miles System Minicleat
FDA 510(k) K934058 · Howmedica Corp.
510(k) numberK934058
Submission
- Device name
- Dall Miles System Minicleat
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- August 19, 1993
- Decision date
- February 23, 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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| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Dall Miles System Minicleat cleared by the FDA?
Dall Miles System Minicleat (K934058) received a 510(k) decision of Substantially Equivalent for Some Indications on February 23, 1994, 188 days after the submission was received.
What is the product code of K934058?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.