Stryker Self-Punching ICONIX
FDA 510(k) K172921 · Stryker
510(k) numberK172921
Submission
- Device name
- Stryker Self-Punching ICONIX
- Applicant
- Stryker
San Jose, CA, US - Received
- September 25, 2017
- Decision date
- November 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…HRS · Traditional | 10/06/2024SE |
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| K233741 | Hoffmann LRF SystemKTT · Special | 12/21/2023SE |
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Questions and answers
When was Stryker Self-Punching ICONIX cleared by the FDA?
Stryker Self-Punching ICONIX (K172921) received a 510(k) decision of Substantially Equivalent on November 20, 2017, 56 days after the submission was received.
What is the product code of K172921?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.