Data / Medical devices / United States / Cayenne Medical, Inc.
Cayenne Medical, Inc.: FDA-registered device maker in Scottsdale, AZ, United States, 14 510(k) clearances
Cayenne Medical, Inc. is registered with the FDA (registration 3006108336) in Scottsdale, AZ, United States. It lists 13 device types. The FDA files 14 510(k) clearances under its listings, the newest dated October 5, 2019. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006108336
- Address
- 16597 N. 92ND Street Suite 101, Scottsdale, AZ, United States, 85260
- Owner or operator
- CAYENNE MEDICAL, INC. (9091610)
- Roles
- Manufacturer
- First device listed
- March 6, 2007
- Registered through
- 2027
- Brand names listed
- 1.1mm Nitinol Guide Wire - part of CM-1501, 10mm Paddle Drill - CM-7610, 11mm Paddle Drill - CM-7611, 2.4mm Guide Pin with Suture Eyelet - part of CM-1501, 2mm Nitinol Guide Wire - part of CM-1501, 9mm Paddle drill - CM-7609, AFX® Femoral Implant with Inserter, 10mm x 25mm - CM-2510AFX, AFX® Femoral Implant with Inserter, 9mm x 25mm - CM-2509AFX and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Manufacturer | accessdata.fda.gov |
| Awl | HWJ | 1 | Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Reamer | HTO | 1 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Suture Kit | OVN | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Manufacturer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 5, 2019 | K192428 | AFX Femoral Implant with Inserter | MBI | Substantially Equivalent | Cayenne Medical | accessdata.fda.gov |
| March 21, 2018 | K180274 | Ventix Link Knotless Anchor with Inserter | MBI | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
| October 16, 2017 | K172186 | BioWick X Implant with Driver | MBI | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
| July 24, 2015 | K151068 | SureLock W Suture Anchor | MBI | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
| January 23, 2015 | K143392 | Quattro Bolt Tenodesis Screw | MBI | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
| December 30, 2013 | K132867 | SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM | MBI | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
| August 16, 2013 | K131325 | QUATTRO GL SUTURE ANCHOR | MBI | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
| October 31, 2012 | K122314 | QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY | MBI | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
| October 11, 2012 | K122463 | APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W | MBI | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
| June 4, 2012 | K121413 | CROSSFIX II MEMISCAL REPAIR DEVICE | GAT | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
| January 17, 2012 | K112814 | CUFFINK | MBI | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
| March 4, 2009 | K083612 | APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM | HWC | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
| March 4, 2009 | K083607 | APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM | HWC | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
| February 19, 2008 | K073426 | APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM | HWC | Substantially Equivalent | Cayenne Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 10, 2013 | 80420 | Class II | Terminated | Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324 | A review of complaints identified a trend for drills breaking. | accessdata.fda.gov |
| July 11, 2013 | 80282 | Class II | Terminated | AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction. | Potential for AperFix 24 mm implant breaking inside the drilled femoral socket. | accessdata.fda.gov |
| April 28, 2010 | 80415 | Class II | Terminated | AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring R | A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Arthroscopic
- All makers of Screw, Fixation, Bone
- All makers of Bit, Drill
- All makers of Needle, Suturing, Disposable
- All makers of Tray, Surgical, Instrument
- All makers of Tap, Bone
Updated October 5, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.