FDA.reportPublic FDA data

NA

Primary DI
00840085215582
Brand
NA
Company
HYHTE HOLDINGS, INC.
Model
KB302413D
Catalog number
KB302413D
Device description
ALIF SPACER, TITANIUM
Published
2021-07-28
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840085215582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085215582008400852155828400852155820840085215582

GMDN Terms#

Term, Definition table
TermDefinition
Metallic 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 metal [e.g., titanium (Ti)] 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#

Type, Value, Unit table
TypeValueUnit
Angle25degree
Height13Millimeter
Length24Millimeter
Width30Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7608148047PARKER@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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840085271861NAAZA083000AZA0830002025-02-26
00840085271878NAAZA084000AZA0840002025-02-26
00840085271885NAAZA084001AZA0840012025-02-26
00840085271892NAAZA085000AZA0850002025-02-26
00840085271908NAAZA085001AZA0850012025-02-26
00840085271915NAAZA086000AZA0860002025-02-26
00840085271922NAAZA088035AZA0880352025-02-26
00840085271939NAAZA088040AZA0880402025-02-26
00840085271946NAAZA088045AZA0880452025-02-26
00840085271953NAAZA088050AZA0880502025-02-26
00840085271960NAAZA088055AZA0880552025-02-26
00840085271977NAAZA088060AZA0880602025-02-26
00840085271984NAAZA088065AZA0880652025-02-26
00840085271991NAAZA088070AZA0880702025-02-26
00840085272004NAAZA088075AZA0880752025-02-26
00840085272011NAAZA088080AZA0880802025-02-26
00840085272028NAAZA088085AZA0880852025-02-26
00840085272035NAAZA088090AZA0880902025-02-26
00840085272042NAAZA088095AZA0880952025-02-26
00840085272066NAAZA091000AZA0910002025-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841523178865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178872Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178889Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178896Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178902Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178919Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178926Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178933Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178940Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178957Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178964Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178971Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178988Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178995Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179008Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179015Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179022Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179039Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179046Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179053Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179060Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179077Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179084Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00810141040007Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCOVD2026-03-05
10889981304713MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981304720MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981326241REEF LSeaspine Orthopedics CorporationOVD2026-03-03
00840067210710TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210727TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210734TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20