FDA.report

Zyston® Strut

Primary DI
00880304863620
Brand
Zyston® Strut
Company
BIOMET SPINE LLC
Model
101M2615
Catalog number
101M2615
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
00880304863620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304863620008803048636208803048636200880304863620

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

Other Devices From This Company

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03662663063258Vital Spinal Fixation System727M64002024-05-10
03662663063265Vital Spinal Fixation System727M65102024-05-10
03662663063272Vital Spinal Fixation System727M74002024-05-10
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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

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Primary DIBrandCompanyProduct codePublished
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00840283403194LumiVy™VY SPINE LLCMAX2026-03-24
00840283403200LumiVy™VY SPINE LLCMAX2026-03-24
00840283403217LumiVy™VY SPINE LLCMAX2026-03-24
00840283403224LumiVy™VY SPINE LLCMAX2026-03-24
06009527200096TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200102TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200119TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200126TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200133TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200140TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200157TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200164TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200218TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200225TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200232TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200249TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200256TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200263TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
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04052536018260pezoUlrich GmbH & Co. KGMAX2026-03-16