Cayenne Medical Inc.
FDA Regulatory Profile
Cayenne Medical Inc. appears in FDA public data with 3 recalls, 23 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2571-2018, Class II) was initiated on October 10, 2013. Its most recent 510(k) clearance was granted on October 5, 2019.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 23
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2571-2018 | Class II | Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm | October 10, 2013 |
| Z-2422-2018 | Class II | AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For or | July 11, 2013 |
| Z-2548-2018 | Class II | AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Cori | April 28, 2010 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K192428 | AFX Femoral Implant with Inserter | October 5, 2019 |
| K180274 | Ventix Link Knotless Anchor with Inserter | March 21, 2018 |
| K172186 | BioWick X Implant with Driver | October 16, 2017 |
| K161033 | AFX Femoral Implant With Inserter | August 3, 2016 |
| K151068 | SureLock W Suture Anchor | July 24, 2015 |
| K143473 | Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock A | March 25, 2015 |
| K143392 | Quattro Bolt Tenodesis Screw | January 23, 2015 |
| K132867 | SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM | December 30, 2013 |
| K131325 | QUATTRO GL SUTURE ANCHOR | August 16, 2013 |
| K122314 | QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY | October 31, 2012 |
| K122463 | APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERF | October 11, 2012 |
| K121413 | CROSSFIX II MEMISCAL REPAIR DEVICE | June 4, 2012 |
| K112814 | CUFFINK | January 17, 2012 |
| K112960 | LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE | January 9, 2012 |
| K112876 | CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR | December 15, 2011 |
| K083607 | APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM | March 4, 2009 |
| K083612 | APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM | March 4, 2009 |
| K082518 | DUAL NEEDLE SUTURE PASSER SYSTEM | January 16, 2009 |
| K073426 | APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM | February 19, 2008 |
| K073054 | MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER | November 27, 2007 |