FDA.report

Zeus

Primary DI
00840916120450
Brand
Zeus
Company
SPINAL ELEMENTS
Model
62-142550-21
Device description
Zeus-L, Lateral Lumber Interbody Fusion Device, 25mm x 50mm x 14mm, 21 degree Lordosis
Published
2019-03-25
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

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
00840916120450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916120450008409161204508409161204500840916120450

GMDN Terms

TermDefinition
Interspinous spinal fixation implantAn implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
004022104
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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

Primary DIBrandModelCatalogPublished
00840916161842ZEUS-L101272021-04-09
00840916161859ZEUS-L18-10402021-04-09
00840916161866ZEUS-L05-10-32021-04-09
00840916150693SAVANNAHSP-0264-6.52020-04-29
00840916161989DIAMOND70012022-03-03
00840916161996DIAMOND100112022-03-03
00840916162009DIAMOND100162022-03-03
00840916162023DIAMOND10013-102022-03-03
00840916162030DIAMOND10013-122022-03-03
00840916162047DIAMOND10013-142022-03-03
00840916162054DIAMOND10013-162022-03-03
00840916162061DIAMOND10013-182022-03-03
00840916162078DIAMOND10014-402022-03-03
00840916162085DIAMOND10021-B2022-03-03
00840916162092DIAMOND10025-2-F-B2022-03-03
00840916162108DIAMOND10025-2-V-B2022-03-03
00840916162115DIAMOND100402022-03-03
00840916162122DIAMOND100432022-03-03
00840916162139DIAMOND100472022-03-03
00840916162146DIAMOND100482022-03-03

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