FDA.report

Zyston Interbody Spacer System

Primary DI
03662663174459
Brand
Zyston Interbody Spacer System
Company
Highridge Medical, LLC
Model
14-534300
Catalog number
14-534300
Device description
Zyst Str Tray Modular Convex Trial
Published
2025-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LRPTRAY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663174459PrimaryGS10

GMDN Terms

TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)447-3625usbrocustomerservice@highridgemedical.com

Regulatory Flags

DUNS number
119260394
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03662663130929Zyston Interbody Spacer System136M3306136M33062026-03-17
03662663130936Zyston Interbody Spacer System136M3307136M33072026-03-17
03662663131117Zyston Interbody Spacer System139M2606139M26062026-03-17
03662663136693Polaris 5.5 Spinal Fixation System14-50181014-5018102026-03-17
03662663136709Polaris 5.5 Spinal Fixation System14-50181114-5018112026-03-17
03662663136723Polaris 5.5 Spinal Fixation System14-50181314-5018132026-03-17
03662663143462MaxAn Anterior Cervical Plate System14-52203814-5220382026-03-17
03662663143479MaxAn Anterior Cervical Plate System14-52203914-5220392026-03-17
03662663143486MaxAn Anterior Cervical Plate System14-52204014-5220402026-03-17
03662663143493MaxAn Anterior Cervical Plate System14-52204114-5220412026-03-17
03662663143509MaxAn Anterior Cervical Plate System14-52204214-5220422026-03-17
03662663143516MaxAn Anterior Cervical Plate System14-52204314-5220432026-03-17
03662663143523MaxAn Anterior Cervical Plate System14-52204414-5220442026-03-17
03662663143530MaxAn Anterior Cervical Plate System14-52204514-5220452026-03-17
03662663085458FlareHawkASY-00003ASY-000032025-10-03
03662663085502FlareHawkASY-00018ASY-000182025-10-03
03662663085533FlareHawkASY-00040ASY-000402025-10-03
03662663085540FlareHawkASY-00041ASY-000412025-10-03
03662663085632FlareHawkASY-00064ASY-000642025-10-03
03662663085663FlareHawkASY-00067ASY-000672025-10-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04046826447953Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
04046826495923Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
04046826495978Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
50198956435382CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-24
50198956248968CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956284027CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956293043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956304954CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956305630CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956308433CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956313703CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956322590CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956325607CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956331677CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956332292CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956348255CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956356526CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956362428CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956367799CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956389128CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956401158CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956408027CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956411966CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956417685CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956418538CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956425918CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956427882CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956428865CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956431551CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956435009CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23