Depuy Modified Skeletal Traction Pin
FDA 510(k) K761088 · Depuy, Inc.
510(k) numberK761088
Submission
- Device name
- Depuy Modified Skeletal Traction Pin
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- November 22, 1976
- Decision date
- December 17, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JEC – Component, Traction, Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Depuy Modified Skeletal Traction Pin cleared by the FDA?
Depuy Modified Skeletal Traction Pin (K761088) received a 510(k) decision of Substantially Equivalent on December 17, 1976, 25 days after the submission was received.
What is the product code of K761088?
The FDA product code is JEC – Component, Traction, Invasive, a Class II (moderate risk) device regulated under 21 CFR 888.3040.