FDA.report

Zyston® Strut

Primary DI
00880304863729
Brand
Zyston® Strut
Company
BIOMET SPINE LLC
Model
101M3115
Catalog number
101M3115
Published
2018-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304863729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304863729008803048637298803048637290880304863729

GMDN Terms

TermDefinition
Surgical tamp, reusableA hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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