Zyston Interbody Spacer System 14-533109

GUDID 03662663155106

Curve Spacer 9H x 27L 0°

Highridge Medical, LLC

Polymeric spinal interbody fusion cage
Primary Device ID03662663155106
NIH Device Record Key3c35848c-20ca-4141-88f8-b078816d715a
Commercial Distribution StatusIn Commercial Distribution
Brand NameZyston Interbody Spacer System
Version Model Number14-533109
Catalog Number14-533109
Company DUNS119260394
Company NameHighridge Medical, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS103662663155106 [Primary]

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-23
Device Publish Date2026-02-13

On-Brand Devices [Zyston Interbody Spacer System]

03662663155069CURVE CARRYING CASE, PARALLEL
03662663155052CURVE MIS TRIAL HOLDER SHAFT
03662663155045CURVE MIS TRIAL HOLDER
03662663155038CURVE STARTER TAMP
03662663155014CURVE TRIAL HOLDER SHAFT
03662663154994CURVE TRIAL 18HX32L 0 DEG
03662663154987CURVE TRIAL 17HX32L 0 DEG
03662663154970CURVE TRIAL 16HX32L 0 DEG
03662663154963CURVE TRIAL 15HX32L 0 DEG
03662663154956CURVE TRIAL 14HX32L 0 DEG
03662663154949CURVE TRIAL 13HX32L 0 DEG
03662663154932CURVE TRIAL 12HX32L 0 DEG
03662663154925CURVE TRIAL 11HX32L 0 DEG
03662663154918CURVE TRIAL 10HX32L 0 DEG
03662663154901CURVE TRIAL 9HX32L 0 DEG
03662663154895CURVE TRIAL 8HX32L 0 DEG
03662663154888CURVE TRIAL 7HX32L 0 DEG
03662663154871CURVE TRIAL 6HX32L 0 DEG
03662663154864CURVE ANGLED TAMP
03662663154857CURVE STRAIGHT TAMP
03662663154840CURVE IMPLANT REMOVER
03662663154833CURVE TRIAL 18HX27L 0 DEG
03662663154826CURVE TRIAL 17HX27L 0 DEG
03662663154819CURVE TRIAL 16HX27L 0 DEG
03662663154802CURVE TRIAL 15HX27L 0 DEG
03662663154796CURVE TRIAL 14HX27L 0 DEG
03662663154789CURVE TRIAL 13HX27L 0 DEG
03662663154772CURVE TRIAL 12HX27L 0 DEG
03662663154765CURVE TRIAL 11HX27L 0 DEG
03662663154758CURVE TRIAL 10HX27L 0 DEG
03662663154741CURVE TRIAL 9HX27L 0 DEG
03662663154734CURVE TRIAL 8HX27L 0 DEG
03662663154727CURVE TRIAL 7HX27L 0 DEG
03662663154710CURVE TRIAL 6HX27L 0 DEG
03662663130967Curved Trial 33L x 10H x 10W mm
03662663130950Curved Trial 33L x 09H x 10W mm
03662663130943Curved Trial 33L x 08H x 10W mm
03662663130912Curved Trial 28L x 16H x 11W mm
03662663130905Curved Trial 28L x 15H x 11W mm
03662663130899Curved Trial 28L x 14H x 11W mm
03662663130882Curved Trial 28L x 13H x 11W mm
03662663130875Curved Trial 28L x 12H x 10W mm
03662663130868Curved Trial 28L x 11H x 10W mm
03662663130851Curved Trial 28L x 10H x 10W mm
03662663130844Curved Trial 28L x 09H x 10W mm
03662663130837Curved Trial 28L x 08H x 10W mm
03662663130820Curved Trial 28L x 07H x 10W mm
03662663192941FORCEPS BIPOLAR DIA1.0MM ANGLED TIPS
03662663192934FORCEPS BIPOLAR DIA1.5MM STRAIGHT TIPS
03662663131216Straight Trial 26L x 16H x 11W mm
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