FDA.report

NA

Primary DI
00840085252136
Brand
NA
Company
HYHTE HOLDINGS, INC.
Model
GM1650FHD
Catalog number
GM1650FHD
Device description
LLIF SPACER, EXPANDABLE, FIXATED, HYPERLORDOTIC
Published
2023-05-22
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840085252136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085252136008400852521368400852521360840085252136

GMDN Terms

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

TypeValueUnit
Angle15degree
Height12Millimeter
Length50Millimeter
Width16Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
00763000663315ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-19
00763000663322ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-19
00763000663360ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-19
00840283402197VyPlate™VY SPINE LLCKWQ2026-03-19
00840283402203VyPlate™VY SPINE LLCKWQ2026-03-19
08800071055440ASTEROSTEONIC CO.,Ltd.KWQ2026-03-19
00763000889982VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000889999VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890001VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890018VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890025VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890032VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890049VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890056VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890063VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890070VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890087VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890094VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890100VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890117VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890124VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890131VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890148VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890155VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890162VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890179VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890186VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890193VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890209VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890216VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16