AFX Femoral Implant With Inserter
FDA 510(k) K161033 · Cayenne Medical, Inc.
510(k) numberK161033
Submission
- Device name
- AFX Femoral Implant With Inserter
- Applicant
- Cayenne Medical, Inc.
Scottsdale, AZ, US - Received
- April 13, 2016
- Decision date
- August 3, 2016
- 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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More from ZheJiang Decans Medical Devices Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K192428 | AFX Femoral Implant with InserterMBI · Special | 10/05/2019SE |
| K180274 | Ventix Link Knotless Anchor with InserterMBI · Traditional | 03/21/2018SE |
| K172186 | BioWick X Implant with DriverMBI · Traditional | 10/16/2017SE |
| K151068 | SureLock W Suture AnchorMBI · Traditional | 07/24/2015SE |
| K143473 | Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles…MBI · Traditional | 03/25/2015SE |
| K143392 | Quattro Bolt Tenodesis ScrewMBI · Traditional | 01/23/2015SE |
| K132867 | Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…MBI · Traditional | 12/30/2013SE |
| K131325 | Quattro GL Suture AnchorMBI · Traditional | 08/16/2013SE |
| K122314 | Quatro Link Knotless Anchor with Inserter, 2.9MM-PEEK OnlyMBI · Traditional | 10/31/2012SE |
| K122463 | Aperfix Am Femoral Implant with Inserter, 9X24 Aperfix Am Femoral Implant with Inserter…MBI · Special | 10/11/2012SE |
Questions and answers
When was AFX Femoral Implant With Inserter cleared by the FDA?
AFX Femoral Implant With Inserter (K161033) received a 510(k) decision of Substantially Equivalent on August 3, 2016, 112 days after the submission was received.
What is the product code of K161033?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.