Cable-Ease Plate and Cable System - Trochanteric Hook
FDA 510(k) K950027 · Intermedics Orthopedics
510(k) numberK950027
Submission
- Device name
- Cable-Ease Plate and Cable System - Trochanteric Hook
- Applicant
- Intermedics Orthopedics
Austin, TX, US - Received
- January 4, 1995
- Decision date
- March 6, 1995
- 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 Cable-Ease Plate and Cable System - Trochanteric Hook cleared by the FDA?
Cable-Ease Plate and Cable System - Trochanteric Hook (K950027) received a 510(k) decision of Substantially Equivalent for Some Indications on March 6, 1995, 61 days after the submission was received.
What is the product code of K950027?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.