FDA.report

Epiphany

Primary DI
B528PSL5022120
Brand
Epiphany
Company
PANTHEON SPINAL, LLC
Model
1
Catalog number
PSL 50-22-12
Device description
Spann LLIF Cage 50x22x12mm
Published
2020-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
B528PSL5022120PrimaryHIBCC0

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
Height12Millimeter
Length50Millimeter
Width22Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
5122154888info@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
true

Other Devices From This Company

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B528XL12184080Yellowstone1XL121840-82021-10-07
B528XL12184580Yellowstone1XL121845-82021-10-07
B528XL12185080Yellowstone1XL121850-82021-10-07
B528XL12185580Yellowstone1XL121855-82021-10-07
B528XL12186080Yellowstone1XL121860-82021-10-07
B528XL12186580Yellowstone1XL121865-82021-10-07
B528XL12187080Yellowstone1XL121870-82021-10-07
B528XL14182080Yellowstone1XL141820-82021-10-07
B528XL14182580Yellowstone1XL141825-82021-10-07
B528XL14183080Yellowstone1XL141830-82021-10-07
B528XL14183580Yellowstone1XL141835-82021-10-07
B528XL14184080Yellowstone1XL141840-82021-10-07
B528XL14184580Yellowstone1XL141845-82021-10-07
B528XL14185080Yellowstone1XL141850-82021-10-07
B528XL14185580Yellowstone1XL141855-82021-10-07
B528XL10184080Yellowstone1XL101840-82021-10-02
B528XL10184580Yellowstone1XL101845-82021-10-02
B528XL10185080Yellowstone1XL101850-82021-10-02
B528XL10185580Yellowstone1XL101855-82021-10-02
B528XL10186080Yellowstone1XL101860-82021-10-02

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