FDA.report

Omni Pirahna

Primary DI
00840916112417
Brand
Omni Pirahna
Company
SPINAL ELEMENTS
Model
P3-0064
Device description
3-L CERV PLATE-64mm
Published
2017-07-10
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

CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840916112417PrimaryGS10

GMDN Terms

TermDefinition
Cervical total disc replacement prosthesis, non-sterileA non-sterile implantable device designed to replace most or all of a dysfunctional intervertebral disc in the cervical spine. It is made of synthetic polymer material(s) [e.g., polyetheretherketone (PEEK)] and typically has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below, to facilitate motion usually through the sliding action of its smooth surfaces. This device is intended to be sterilized before use.

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

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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00763000663360ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-19
00840283402197VyPlate™VY SPINE LLCKWQ2026-03-19
00840283402203VyPlate™VY SPINE LLCKWQ2026-03-19
08800071055440ASTEROSTEONIC CO.,Ltd.KWQ2026-03-19
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00763000890131VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890148VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890155VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
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00763000890179VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890186VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890193VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
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