CMC Cable Fix
FDA 510(k) K111032 · Instratek, Inc.
510(k) numberK111032
Submission
- Device name
- CMC Cable Fix
- Applicant
- Instratek, Inc.
Houston, TX, US - Received
- April 13, 2011
- Decision date
- August 31, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was CMC Cable Fix cleared by the FDA?
CMC Cable Fix (K111032) received a 510(k) decision of Substantially Equivalent on August 31, 2011, 140 days after the submission was received.
What is the product code of K111032?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.