FDA.reportPublic FDA data

Epiphany

Primary DI
B52810310
Brand
Epiphany
Company
PANTHEON SPINAL, LLC
Model
1
Catalog number
103-1
Device description
Access Case
Published
2018-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113781000PANTHEON SPINAL IBFD SYSTEMPantheon Spinal2013-04-26MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B52810310PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5122154888info@pantheon-spinal.com

Regulatory Flags#

DUNS number
071012634
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B528100800001003020EPIPHANY11008-0000 1003-022018-01-21
B528100900001003030EPIPHANY11009-0000 1003-032018-01-21
B528101000000EPIPHANY11010-00002018-01-21
B528101100000EPIPHANY11011-00002018-01-21
B528101200000EPIPHANY11012-00002018-01-21
B528PSM11W0Orion Sacroiliac Joint Fusion System1PS-M11W2020-10-12
B528PSM13W0Orion Sacroiliac Joint Fusion System1PS-M13W2020-10-12
B528100213010Yellowstone11002-13012018-05-26
B528100213020Epiphany11002-13022018-05-26
B528100310011022110Epiphany11003-1001 1022-112018-05-26
B528100310021022120Epiphany11003-1002 1022-122018-05-26
B528100418011023010EPIPHANY11004-1801 1023-012018-01-21
B528100418021023020EPIPHANY11004-1802 1023-022018-01-21
B528100418041023040EPIPHANY11004-1804 1023-042018-01-21
B528XL12184080Yellowstone1XL121840-82021-10-07
B528XL12184580Yellowstone1XL121845-82021-10-07
B528XL12185080Yellowstone1XL121850-82021-10-07
B528XL12185580Yellowstone1XL121855-82021-10-07
B528XL12186080Yellowstone1XL121860-82021-10-07
B528XL12186580Yellowstone1XL121865-82021-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02
08800043964268N/ATDM Co., Ltd.MAX2026-06-02