FDA.report

Zyston Interbody Spacer System

Primary DI
03662663156011
Company
Highridge Medical, LLC
Model
14-533626
Catalog number
14-533626
Device description
8MM STRAIGHT RASP
Published
2025-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

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
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
03662663156011PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
03662663156011PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
HTRRasp1General, Plastic Surgery878.4800NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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
00889024706927Z1 Shortened Starter BroachZimmer, Inc.HTR2026-03-19
10889981443351SpecialsSeaspine Orthopedics CorporationHTR2026-03-03
10889981443368SpecialsSeaspine Orthopedics CorporationHTR2026-03-03
00190776416690MillenniumAvalign Technologies, Inc.HTR2026-02-16
03662663109574Mergence-A Preparation InstrumentationHighridge Medical, LLCHTR2026-02-11
00190376538969Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTR2026-02-10
00190376538976Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTR2026-02-10
03662663083720ActivLHighridge Medical, LLCHTR2026-02-03
03662663083737ActivLHighridge Medical, LLCHTR2026-02-03
03662663083744ActivLHighridge Medical, LLCHTR2026-02-03
00889024705524Identity 40MM Inset Humeral ProtectorZimmer, Inc.HTR2026-01-16
00840180543955General InstrumentsALPHATEC SPINE, INC.HTR2025-12-31
00840180545058General InstrumentsALPHATEC SPINE, INC.HTR2025-12-31
00888480490289Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490296Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490302Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490319Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490326Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490333Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490340Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490357Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490364Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490371Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490388Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490395Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490401Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490418Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490425Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490432Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490449Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29