FDA.report

NA

Primary DI
00840085271069
Brand
NA
Company
HYHTE HOLDINGS, INC.
Model
TBB016140
Catalog number
TBB016140
Device description
VARIABLE LORDOSIS ENDPLATE
Published
2024-10-22
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840085271069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085271069008400852710698400852710690840085271069

GMDN Terms

TermDefinition
Cervical intervertebral disc prosthesis endplateAn implantable, disc-like component of a modular cervical total intervertebral disc prosthesis designed to be used in pairs for attachment to the prepared vertebrae above and below the excised natural disc, and within which is positioned the core component (not included) of the prosthesis, to replace a dysfunctional intervertebral disc in the cervical spine; it is not the complete prosthesis assembly. It typically has a serrated surface, or flange, to facilitate attachment to the vertebrae and is made of metallic materials.

Device Sizes

TypeValueUnit
Depth16Millimeter
Length14Millimeter
Outer Diameter12Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
7608148047TROY@ASTURAMEDICAL.COM

Regulatory Flags

DUNS number
073029645
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

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