FDA.report

Trident Anchor Cervical

Primary DI
B528PS2299230
Brand
Trident Anchor Cervical
Company
PANTHEON SPINAL, LLC
Model
1
Catalog number
PS22-99-23
Device description
8mm x 12mm x 14mm 5 degree Anterior Cervical Interbody
Published
2020-10-06
Public version status
New
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
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B528PS2299230PrimaryHIBCC0

GMDN Terms

TermDefinition
Polymeric spinal interbody fusion cageA 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.

Device Sizes

TypeValueUnit
Angle5degree
Depth12Millimeter
Height8Millimeter
Width14Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
5123083488info@pantheon-spinal.com

Regulatory Flags

DUNS number
071012634
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
false

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B528XL10185580Yellowstone1XL101855-82021-10-02
B528XL10186080Yellowstone1XL101860-82021-10-02

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