FDA.reportPublic FDA data

NA

Primary DI
00841379183457
Brand
NA
Company
HYHTE HOLDINGS, INC.
Model
DE181515C
Catalog number
DE181515C
Device description
CORPECTOMY SPACER
Published
2021-07-30
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
PLRSpinal Vertebral Body Replacement Device - Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLRSpinal Vertebral Body Replacement Device - CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841379183457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841379183457008413791834578413791834570841379183457

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Angle7degree
Height15Millimeter
Length15Millimeter
Width18Millimeter

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
04046826414870MediExpand Cervical Expandable VBR System Medicon eG. Chirurgiemechaniker-GenossenschaftPLR2025-07-31
04046826415471MediExpand Cervical Expandable VBR System Medicon eG. Chirurgiemechaniker-GenossenschaftPLR2025-07-31
04046826415488MediExpand Cervical Expandable VBR System Medicon eG. Chirurgiemechaniker-GenossenschaftPLR2025-07-31
04046826415495MediExpand Cervical Expandable VBR System Medicon eG. Chirurgiemechaniker-GenossenschaftPLR2025-07-31
04046826415501MediExpand Cervical Expandable VBR System Medicon eG. Chirurgiemechaniker-GenossenschaftPLR2025-07-31
04046826415518MediExpand Cervical Expandable VBR System Medicon eG. Chirurgiemechaniker-GenossenschaftPLR2025-07-31
04046826420413MediExpand Cervical Expandable VBR System Medicon eG. Chirurgiemechaniker-GenossenschaftPLR2025-07-31
04046826420420MediExpand Cervical Expandable VBR System Medicon eG. Chirurgiemechaniker-GenossenschaftPLR2025-07-31
04046826420437MediExpand Cervical Expandable VBR System Medicon eG. Chirurgiemechaniker-GenossenschaftPLR2025-07-31
04046826414887MediExpand Cervical Expandable VBR System Medicon eG. Chirurgiemechaniker-GenossenschaftPLR2025-07-18
00190376632728AscendALPHATEC SPINE, INC.PLR2025-04-03
00190376632735AscendALPHATEC SPINE, INC.PLR2025-04-03
00190376633015AscendALPHATEC SPINE, INC.PLR2025-04-03
00190376633022AscendALPHATEC SPINE, INC.PLR2025-04-03
00190376633039AscendALPHATEC SPINE, INC.PLR2025-04-03
00190376633176AscendALPHATEC SPINE, INC.PLR2025-04-03
00190376633206AscendALPHATEC SPINE, INC.PLR2025-04-03
00190376643694AscendALPHATEC SPINE, INC.PLR2025-04-03
00190376643700AscendALPHATEC SPINE, INC.PLR2025-04-03
00190376643717AscendALPHATEC SPINE, INC.PLR2025-04-03
00190376643724AscendALPHATEC SPINE, INC.PLR2025-04-03
00190376657325AscendALPHATEC SPINE, INC.PLR2025-04-03
00889929065754Matrixx SystemNEXXT SPINE, LLCPLR2025-03-19
00889929065761Matrixx SystemNEXXT SPINE, LLCPLR2025-03-19
00889929065778Matrixx SystemNEXXT SPINE, LLCPLR2025-03-19
00889929065785Matrixx SystemNEXXT SPINE, LLCPLR2025-03-19
00889929065792Matrixx SystemNEXXT SPINE, LLCPLR2025-03-19
00889929065808Matrixx SystemNEXXT SPINE, LLCPLR2025-03-19
00889929065815Matrixx SystemNEXXT SPINE, LLCPLR2025-03-19
00889929065822Matrixx SystemNEXXT SPINE, LLCPLR2025-03-19