ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor
FDA 510(k) K173074 · Stryker
510(k) numberK173074
Submission
- Device name
- ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor
- Applicant
- Stryker
Greenwood Village, CO, US - Received
- September 29, 2017
- Decision date
- April 4, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K261632 | Thunderbolt SystemMBI · Special | Responsive Arthroscopy, Inc. | 07/20/2026SE |
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Questions and answers
When was ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor cleared by the FDA?
ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor (K173074) received a 510(k) decision of Substantially Equivalent on April 4, 2018, 187 days after the submission was received.
What is the product code of K173074?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.