FDA.report

Zyston® Straight Spacer System

Primary DI
00880304823587
Brand
Zyston® Straight Spacer System
Company
BIOMET SPINE LLC
Model
14-534849
Catalog number
14-534849
Published
2020-07-07
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
MAXIntervertebral fusion device with bone graft, lumbar
MQPSpinal vertebral body replacement device

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304823587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304823587008803048235878803048235870880304823587

GMDN Terms

TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)447-3625USBROCustomerService@zimmerbiomet.com

Regulatory Flags

DUNS number
018577570
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03662663063234Vital Spinal Fixation System727M54002024-05-10
03662663063241Vital Spinal Fixation System727M55102024-05-10
03662663063258Vital Spinal Fixation System727M64002024-05-10
03662663063265Vital Spinal Fixation System727M65102024-05-10
03662663063272Vital Spinal Fixation System727M74002024-05-10
03662663063289Vital Spinal Fixation System727M75102024-05-10
03662663063296Vital Spinal Fixation System727M84002024-05-10
03662663063302Vital Spinal Fixation System727M85102024-05-10
03662663063524Vital Spinal Fixation System727M54012024-05-10
03662663063531Vital Spinal Fixation System727M54022024-05-10
03662663063548Vital Spinal Fixation System727M55112024-05-10
03662663063555Vital Spinal Fixation System727M55122024-05-10
03662663063562Vital Spinal Fixation System727M64012024-05-10
03662663063579Vital Spinal Fixation System727M64022024-05-10
03662663063586Vital Spinal Fixation System727M65112024-05-10
03662663063593Vital Spinal Fixation System727M65122024-05-10
03662663063609Vital Spinal Fixation System727M74012024-05-10
03662663063616Vital Spinal Fixation System727M74022024-05-10
03662663063623Vital Spinal Fixation System727M75112024-05-10
03662663063630Vital Spinal Fixation System727M75122024-05-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800322740446Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740453Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740460Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740477Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740484Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740491Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740507Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740514Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740521Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740538Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740545Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740552Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740569Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740576Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740583Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740590Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740606Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740613Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740620Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740637Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740644Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740651Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740668Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740675Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740682Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740699Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740705Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740712Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740729Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740736Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23