Cable Ready Cable Grip System Cable Button
FDA 510(k) K091799 · Zimmer, Inc.
510(k) numberK091799
Submission
- Device name
- Cable Ready Cable Grip System Cable Button
- Applicant
- Zimmer, Inc.
Warsaw, IN, US - Received
- June 17, 2009
- Decision date
- September 11, 2009
- 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 Cable Ready Cable Grip System Cable Button cleared by the FDA?
Cable Ready Cable Grip System Cable Button (K091799) received a 510(k) decision of Substantially Equivalent on September 11, 2009, 86 days after the submission was received.
What is the product code of K091799?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.