CAYENNE MEDICAL, INC.

Registration Details

Registration Name: CAYENNE MEDICAL, INC.
Registration Number: 3006108336
FEI Number: 3006108336
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 16597 N. 92ND STREET, SUITE 101
City: SCOTTSDALE
State: AZ
ZIP: 85260
Country: US

Regulatory Submissions

510(k) Number: K083612

Owner / Operator

Firm Name: CAYENNE MEDICAL, INC.
Operator Number: 9091610
Address: 16597 N. 92ND STREET, SUITE 101
City: Scottsdale
State: AZ
Postal Code: 85260
Country: US
Correspondent: Jessica - Rose

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Cannula, Surgical, General & Plastic Surgery	GEA	Class 1	General, Plastic Surgery	No	2012-02-08
Suture Kit	OVN	Class 2	General, Plastic Surgery	No	2022-10-21
Screw, Fixation, Bone	HWC	Class 2	Orthopedic	No	2013-12-11
Accessories, Arthroscopic	NBH	Class 1	Orthopedic	No	2012-02-07
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	Class 2	Orthopedic	No	2020-01-16
Bit, Drill	HTW	Class 1	Orthopedic	No	2007-03-06
Needle, Suturing, Disposable	GAB	Class 1	General, Plastic Surgery	No	2013-12-11
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	Class 2	General, Plastic Surgery	No	2013-12-11
Orthopedic Manual Surgical Instrument	LXH	Class 1	Orthopedic	No	2007-03-06
Tap, Bone	HWX	Class 1	Orthopedic	No	2012-02-07
Reamer	HTO	Class 1	Orthopedic	No	2012-02-08
Tray, Surgical, Instrument	FSM	Class 1	General, Plastic Surgery	No	2012-02-07
Awl	HWJ	Class 1	Orthopedic	No	2012-02-07

Proprietary Names

AperFix Cannula - part of CM-1501 Suture Kit AperFix® Femoral Implant 9mmx29mm - CM-2909 AperFix® Femoral Implant 11mmx29mm - CM-2911 AperFix® Femoral Implant 10mmx29mm - CM-2910 AperFix 14 AperFix Guide Wire Quattro Suture Passer - CM9010 Quattro Suture Shuttle 45 degree Left - CM-9013 Quattro Offset Glenoid Drill Guide - CM-9303 Quattro GT Suture Passer - CM-9010GT Quattro Rasp- Down Curve - CM-9005 CrossFix Disposable Kit - CM-8000 Mirror Femoral Two Post Drill Guide Handle - 300500 Quattro Tissue Elevator - blade down, CM-9009 Quattro Switching Stick - CM-9012 Quattro Suture Shuttle 35 degree Up - CM-9015 Quattro Drill Guide, 2.9mm - CM-9301 SureLock Drill Guide (straight) 1.4mm - CM-9643 Quattro Tissue Elevator-Blade Up - CM-9008 SureLock Obturator 2.2mm - CM-9621 SureLock Drill Guide (curved 25 degree) 1.4mm - CM-9645 Quattro Suture Cutter - CM-9001 Quattro Suture Grasper - CM-9016 Quattro Suture Shuttle 45 degree Right - CM-9014 CrossFix Malleable Introducer - CM-8010 Quattro Knot Pusher - CM-9007 Mirror Femoral Two Post Drill Guide - Size 50mm - 300497 Mirror Femoral Two Post Drill Guide - Size 42mm - 300495 Quattro Tissue Grasper - CM-9002 Quattro Rasp-Up Curve - CM-9006 Mirror Femoral Two Post Drill Guide - Size 54mm - 300498 Mirror PrFC Distraction Platform - 300103 Quattro Suture Manipulator - CM-9003 SureLock Obturator 1.4mm - CM-9641 Quattro Obturator, Blunt, 2.9mm - CM-9302 Mirror Femoral Two Post Drill Guide - Size 46mm - 300496 Quattro Lock-Stitch Suture Passer - CM-9010LS Quattro Probe - CM-9004 AperFix Tibial Drill Guide System - CM-7320 SureLock Drill Guide (curved 25 degree) 2.2mm - CM-9625 SureLock Drill Guide (straight) 2.2mm - CM-9623 Mirror Femoral Two Post Drill Guide - Size 38mm - 300494 Universal Instrument Set - Universal - CM-9000U Drill Guide for Short SureLock All Suture Anchor - CM-9600 BioWick SureLock Obturator - CM-6121 BioWick SureLock Drill Guide - CM-6120 AFX® Femoral Implant with Inserter, 10mm x 25mm - CM-2510AFX AFX® Femoral Implant with Inserter, 9mm x 25mm - CM-2509AFX Accessory Portal Kit Drill Quattro Knotless Anchor Drill 4.5mm SP - CM-9138 AperFix Tibial Drill, 8mm - CM-7308 SureLock Drill, 1.4mm SureLock, Flex - CM-9640S SureLock Drill, 2.2mm - CM-9620 AperFix Femoral Drill, 9mm - CM-7209 AperFix Guide Wire (2.4mm) - CM-7013 AperFix Femoral Drill, 7mm - CM-7207 SureLock Drill, 1.4mm - CM-9640 Mirror Femoral Two Post Drill - 300501 9mm Paddle drill - CM-7609 CM-9580 Accessory Drill Kit, 8mm AperFix Femoral Drill, 11mm - CM-7211 SureLock Drill, 2.2mm SureLock, Flex - CM-9620S AperFix Femoral Drill, 10mm - CM-7210 AperFix Drill Tip Guide Wire (2.4mm) 14 Quattro Knotless Anchor Drill 5.5mm - CM-9148 AperFix Tibial Drill, 11mm - CM-7311 CM-9570 Accessory Drill Kit, 7mm AperFix Femoral Drill, 8mm - CM-7208 CM-6101, BioWick SureLock Drill, 2.7mm Quattro Knotless Anchor Drill 4.5/5.5mm - CM-9130 AperFix Tibial Drill, 7mm - CM-7307 AperFix Tibial Drill, 10mm - CM-7310 Mirror Tibia Drill - 300326 AperFix Tibial Drill, 9mm - CM-7309 CM-9540 Accessory Drill Kit, 4mm 10mm Paddle Drill - CM-7610 Quattro Spade Drill, for 2.9mm - CM-9300 AperFix Femoral Implant Screw Removal Drill - CM-7201 Quattro Drill 2.4mm, Hard Bone - CM-9234 2.4mm Guide Pin with Suture Eyelet - part of CM-1501 CM-9550 Accessory Drill Kit, 5mm 11mm Paddle Drill - CM-7611 CM-9560 Accessory Drill Kit, 6mm Product Name Hard Bone Drill, 2.7mm, BioWick SureLock - CM-6101H Quattro Drill 2.4mm, Hard Bone - CM-9324 Hard Bone Drill, with Centering Sleeve, for 1.4mm SureLock All-Suture Anchor - CM-9640HS Drill, for 2.9mm Quattro Suture Anchors - CM-9300ST Drill, Hard Bone, for 2.9mm Quattro Anchors - CM-9324ST Femoral Two Post Drill - 300501 Hard Bone Drill, Straight 1.4mm Disposable Drill - CM-9640H Tibia Drill - 300326 AperFix Drill Tip Guide Wire (2.4mm) 14" - CM-7014 Disposable Drill, for 4.75mm Ventix Link Knotless Anchor - 110026002 Disposable Drill, for 5.5mm Ventix Link Knotless Anchor - 110026003 Quattro GL Suture Anchor, 2.9mm - CM-9329 Quattro GL2 Suture Anchor, 2.9mm - CM-9329GL2 iFix Interference Screw - 8mm x 30mm - CM-1830 iFix Interference Screw - 12mm x 30mm - CM-1230 iFix Interference Screw - 9mm x 25mm - CM-1925 iFix Interference Screw - 8mm x 25mm - CM-1825 iFix Interference Screw - 11mm x 30mm - CM-1130 iFix Interference Screw - 10mm x 25mm - CM-1025 iFix Interference Screw - 9mm x 30mm - CM-1930 iFix Interference Screw - 10mm x 30mm - CM-1030 iFix Interference Screw - 8mm x 20mm - CM-1820 iFix Interference Screw - 7mm x 20mm - CM-1720 iFix Interference Screw - 7mm x 25mm - CM-1725 iFix Interference Screw - 9mm x 20mm - CM-1920 CM-6255 BioWick X Pre-loaded Implant with Driver 5.5mm CM-6265 BioWick X Pre-loaded Implant with Driver 6.5mm CM-9508 Quattro® Bolt Tendesis Screw, 8mm by 16mm CM-9505 Quattro® Bolt Tendesis Screw, 5mm by 10mm CM-9509 Quattro® Bolt Tendesis Screw, 9mm by 16mm CM-9506 Quattro® Bolt Tendesis Screw, 6mm by 12mm CM-9507 Quattro® Bolt Tendesis Screw, 7mm by 14mm Quattro Link Knotless Anchor, 4.5mm - CM-9145 Quattro Link Knotless Anchor, 5.5mm - CM-9155 Quattro Link Knotless Anchor, 2.9mm - CM-9129 Quattro Link Knotless Anchor 4.5mm SP - CM-9145SP Quattro Suture Needle, CM-9011 CROSSFIX II MEMISCAL REPAIR DEVICE APERFIX SYSTEM ACL INSTRUMENT SET - CM-7000 1.1mm Nitinol Guide Wire - part of CM-1501 Suture loop, size #5 - part of accessory portal kit CM-7609, CM-7610, and CM-7611 2mm Nitinol Guide Wire - part of CM-1501 Graft Dilator, 11mm - CM-7411 iFix Tapered Dilator - CM-7607 Mirror Femoral Impactor - 300096 AperFix Tibial Implant Removal Tool - CM-7300 Mirror Tibial Press Tool - 300097 Mirror Pin Puller - 300122 Graft Dilator, 10mm - CM-7410 Graft Dilator, 9mm - CM-7409 iFix Interference Screw Inserter 3.45mm - CM-1345 AperFix Femoral Implant Removal Tool - CM-7200 iFix Interference Screw Inserter 2.45mm - CM-1245 iFix Pin Puller - CM-7120 AperFix®II AM Femoral Implant 10mmx24mm - CM-2410 AperFix®II AM Femoral Implant 9mmx24mm - CM-2409 Quattro Tap, 5.5mm Suture Anchor - CM-9201 Quattro Tap, 5.5mm Quattro X3 Suture Anchor - CM-9203 Quattro Tap, 6.5mm Suture Anchor - CM-9202 BioWick X Tap, 5.5mm - CM-6201 BioWick X Tap, 6.5mm - CM-6202 Tap, 4.75mm Ventix Link Knotless - 110026000 Tap, 5.5mm Ventix Link Knotless - 110026001 SureLock All-Suture, 1.4mm - CM-9614 SureLock All-Suture, 2.2mm , Flex - CM-9622F SureLock All-Suture, 2.2mm - CM-9622 SureLock All-Suture, 1.4mm , Flex - CM-9614F AperFix Femoral Removal Coring Reamer, 9mm - CM-7109ST AperFix Femoral Removal Coring Reamer, 11mm - CM-7111ST AperFix Femoral Removal Coring Reamer, 10mm - CM-7110ST Quattro Tray (QT) - CM-9000QT AperFix Instrument Tray - CM-7001 Accessory Instrument Tray - CM-9000AT Universal Tray (UT) - CM-9000UT CM-6127, BioWick SureLock Implant, 2.7mm Quattro X3 Suture Anchor, 5.5mm pre-load - CM-9255X3 Quattro X Suture Anchor, 5.5mm - CM-9255 Quattro X Suture Anchor, 6.5mm - CM-9265 Quattro X Suture Anchor, 5.5mm, Double Loaded #2 Sliding BroadBand Suture Tape - CM-9255BGS Quattro X Suture Anchor, 5.5mm, Double Loaded #2 BroadBand Suture Tape (1) Non-Sliding (1) Sliding - CM-9255BG Quattro X Suture Anchor, 6.5mm, Double Loaded #2 BroadBand Suture Tape (1) Non-Sliding (1) Sliding - CM-9265BG Quattro X Suture Anchor, 6.5mm, Double Loaded #2 Sliding BroadBand Suture Tape - CM-9265BGS Ventix Link Knotless Anchor with Inserter, 4.75 - 110025990 Ventix Link Knotless Anchor with Inserter, 5.5 - 110025992 Quattro Awl, 4.5/5.5mm - CM-9100 Quattro Awl, 5.5/6.5mm - CM-9200 Awl, 4.75/5.5mm Ventix Link Knotless - 110025998 AperFix®II Cannulated Tibial 9mmx30mm - CM-3009C AperFix®II Cannulated Tibial 10mmx30mm - CM-3010C AperFix® Tibial Implant 8mmx30mm - CM-3008 AperFix®II Cannulated Tibial 11mmx30mm - CM-3011C

Establishment Types

Manufacture Medical Device