Zeua

Primary DI: 00840916123130
Brand: Zeua
Company: SPINAL ELEMENTS
Model: 65-260914
Device description: Zeus-P Implant 14 x 9 x 26mm
Published: 2017-08-06
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: false
Sterile: false
Single use: true

Related Records

Product Codes

Code	Name
FDA	Enteroscope And Accessories

Product Code Classifications

Code	Device	Specialty	Class
FDA	Enteroscope And Accessories	Gastroenterology, Urology	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
00840916123130	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00840916123130	00840916123130	840916123130	0840916123130

GMDN Terms

Term	Definition
Polymeric spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Term

Definition

Polymeric spinal interbody fusion cage

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number: 004022104
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

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00840916161842	ZEUS-L	10127	2021-04-09
00840916161859	ZEUS-L	18-1040	2021-04-09
00840916161866	ZEUS-L	05-10-3	2021-04-09
00840916150693	SAVANNAH	SP-0264-6.5	2020-04-29
00840916161989	DIAMOND	7001	2022-03-03
00840916161996	DIAMOND	10011	2022-03-03
00840916162009	DIAMOND	10016	2022-03-03
00840916162023	DIAMOND	10013-10	2022-03-03
00840916162030	DIAMOND	10013-12	2022-03-03
00840916162047	DIAMOND	10013-14	2022-03-03
00840916162054	DIAMOND	10013-16	2022-03-03
00840916162061	DIAMOND	10013-18	2022-03-03
00840916162078	DIAMOND	10014-40	2022-03-03
00840916162085	DIAMOND	10021-B	2022-03-03
00840916162092	DIAMOND	10025-2-F-B	2022-03-03
00840916162108	DIAMOND	10025-2-V-B	2022-03-03
00840916162115	DIAMOND	10040	2022-03-03
00840916162122	DIAMOND	10043	2022-03-03
00840916162139	DIAMOND	10047	2022-03-03
00840916162146	DIAMOND	10048	2022-03-03

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