Codman Sof'Wire (TM) Kit
FDA 510(k) K915581 · Codman & Shurtleff, Inc.
510(k) numberK915581
Submission
- Device name
- Codman Sof'Wire (TM) Kit
- Applicant
- Codman & Shurtleff, Inc.
Randolph, MA, US - Received
- December 13, 1991
- Decision date
- January 16, 1992
- 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 Codman Sof'Wire (TM) Kit cleared by the FDA?
Codman Sof'Wire (TM) Kit (K915581) received a 510(k) decision of Substantially Equivalent on January 16, 1992, 34 days after the submission was received.
What is the product code of K915581?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.