FDA.report

NA

Primary DI
00840085249693
Brand
NA
Company
HYHTE HOLDINGS, INC.
Model
KZA09BQ06
Catalog number
KZA09BQ06
Device description
PITUITARY, OBLIQUE, STRAIGHT, #6
Published
2022-05-11
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
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840085249693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085249693008400852496938400852496930840085249693

GMDN Terms

TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

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
00810141040007Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCOVD2026-03-05
10889981304713MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981304720MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981326241REEF LSeaspine Orthopedics CorporationOVD2026-03-03
00840067210710TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210727TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210734TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210741TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210758TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210765TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210772TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210789TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210796TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210802TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210819TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210826TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210833TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210840TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210857TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210864TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210871TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210888TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210895TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210901TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210918TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210925TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210932TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210949TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210956TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210963TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20