Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006108336

FEI Number

3006108336

Entity Name

CAYENNE MEDICAL, INC.

City/State/Country

SCOTTSDALE, AZ, US

Establishment Address

16597 N. 92ND STREET, SUITE 101, SCOTTSDALE, AZ 85260, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CAYENNE MEDICAL, INC. (Owner Number: 9091610)

Owner / Operator Contact Address

16597 N. 92ND STREET, SUITE 101, Scottsdale, AZ 85260, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Product Name 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-02-08
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2022-10-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-11
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2012-02-07
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-01-16
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2007-03-06
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-12-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-02-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-01-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-05-06
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-01-25
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-12-11
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-12-11
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-03-06
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-01-25
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2012-02-07
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-01-08
HTO	Reamer	Orthopedic	Class 1	888.4540	2012-02-08

Official Correspondent

Jessica Rose

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CAYENNE MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006108336. Last updated year: 2026. Please use registration number 3006108336 when referencing this establishment in official correspondence.