FDA.reportPublic FDA data

NA

Primary DI
00840085236785
Brand
NA
Company
HYHTE HOLDINGS, INC.
Model
LZC050000
Catalog number
LZC050000
Device description
DRIVER GUIDE, VARIABLE
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
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840085236785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085236785008400852367858400852367850840085236785

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

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

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Primary DI, Brand, Company table
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00810056992958aprevoCarlsmed, Inc.OVE2026-03-17
00763000880422Endoskeleton™ TCS Interbody SystemMEDTRONIC SOFAMOR DANEK, INC.OVE2026-03-02
10195860030407E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
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10195860030469E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
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10195860030490E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030513E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030520E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030544E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030629E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030636E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030643E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030650E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030667E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030681E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030698E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
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10195860030735E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030759E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030773E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030797E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030865E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030872E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030902E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030933E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20