KISSloc Suture System
FDA 510(k) K170440 · Arthrosurface, Inc.
510(k) numberK170440
Submission
- Device name
- KISSloc Suture System
- Applicant
- Arthrosurface, Inc.
Franklin, MA, US - Received
- February 14, 2017
- Decision date
- May 3, 2017
- 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 KISSloc Suture System cleared by the FDA?
KISSloc Suture System (K170440) received a 510(k) decision of Substantially Equivalent on May 3, 2017, 78 days after the submission was received.
What is the product code of K170440?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.