FDA.reportPublic FDA data

NA

Primary DI
00840085236952
Brand
NA
Company
HYHTE HOLDINGS, INC.
Model
LZD040050
Catalog number
LZD040050
Device description
FIXED ANGLE TAP, SHORT
Published
2021-07-27
Public version status
Update
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840085236952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085236952008400852369528400852369520840085236952

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. 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
Primary DIBrandCompanyProduct codePublished
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00840283404252ClariVy™VY SPINE LLCODP2026-03-19
00840283404269ClariVy™VY SPINE LLCODP2026-03-19
00840283404276ClariVy™VY SPINE LLCODP2026-03-19
00840283404283ClariVy™VY SPINE LLCODP2026-03-19
00840493416687LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416694LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416700LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00841193127521EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127538EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127545EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127552EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127569EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127576EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127583EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127590EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127606EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127613EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127620EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127637EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127644EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127651EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127668EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127675EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
10195860030421E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030438E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030445E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030452E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030506E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030537E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20