FDA.report

Zyston Interbody Spacer System

Primary DI
03662663162364
Brand
Zyston Interbody Spacer System
Company
Highridge Medical, LLC
Model
14-535115-04
Catalog number
14-535115-04
Device description
Base, Pit/Kerrison Instr. Kit
Published
2025-12-16
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

Contact Domains

Product Codes

CodeName
HTXRONGEUR

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663162364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03662663162364036626631623643662663162364

GMDN Terms

TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. 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
00199150066872Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-03-20
00192896122864Velociraptor Junior RongeurSONTEC INSTRUMENTS, INC.HTX2026-03-19
00198506089626ELMED INCORPORATEDELMED INCORPORATEDHTX2026-03-17
04052536018314tezoUlrich GmbH & Co. KGHTX2026-03-16
04052536018321tezoUlrich GmbH & Co. KGHTX2026-03-16
04052536017768tezoUlrich GmbH & Co. KGHTX2026-03-12
04052536017775tezoUlrich GmbH & Co. KGHTX2026-03-12
M9308302T00Life InstrumentsLife Instrument CorporationHTX2026-03-06
M9308303T00Life InstrumentsLife Instrument CorporationHTX2026-03-06
M9308304T00Life InstrumentsLife Instrument CorporationHTX2026-03-06
M9308308H0Life InstrumentsLife Instrument CorporationHTX2026-03-06
M930831103330Life InstrumentsLife Instrument CorporationHTX2026-03-06
04058749055276NAFehling Instruments GmbH & Co. KGHTX2026-03-05
04058749097238NAFehling Instruments GmbH & Co. KGHTX2026-03-05
B382SD9228132130Surgical DirectSurgical Direct, Inc.HTX2026-02-17
B382SD922813214Surgical DirectSurgical Direct, Inc.HTX2026-02-17
B382SD62240190Surgical DirectSurgical Direct, Inc.HTX2026-02-10
B382SD62241190Surgical DirectSurgical Direct, Inc.HTX2026-02-10
B382SD91931609Surgical DirectSurgical Direct, Inc.HTX2026-02-10
B382SD62003250Surgical DirectSurgical Direct, Inc.HTX2026-02-09
B382SD923811300Surgical DirectSurgical Direct, Inc.HTX2026-02-09
00199150067114Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067121Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067138Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067145Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067152Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067169Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067176Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067183Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067190Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07