FDA.reportPublic FDA data

N/A

Primary DI
00840085236853
Brand
N/A
Company
HYHTE HOLDINGS, INC.
Model
LZA970000-22
Catalog number
LZA970000-22
Device description
ACSS SPACER, HA PEEK CADDY, LARGE
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
00840085236853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085236853008400852368538400852368530840085236853

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle10degree

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
760-814-8047troy@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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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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10195860030735E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030759E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030773E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
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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