FDA.reportPublic FDA data

HAtetracell™-C

Primary DI
M711LS758200
Brand
HAtetracell™-C
Company
INNO Holdings, Inc.
Model
LS-758-20
Device description
Trial, 15L x 17W x 9-10H x 12°, SST
Published
2024-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231899000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231899000HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.2023-10-17ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LS758200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle12degree
Device Size Text, specify0
Length15Millimeter
Width17Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
801-261-2236info@innovasis.com

Regulatory Flags#

DUNS number
141620464
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M711511410070Endeavor™ Stand-Alone Cervical51-1410072026-05-31
M711511410120Endeavor™ Stand-Alone Cervical51-1410122026-05-31
M711511411070Endeavor™ Stand-Alone Cervical51-1411072026-05-31
M711511411120Endeavor™ Stand-Alone Cervical51-1411122026-05-31
M711511412070Endeavor™ Stand-Alone Cervical51-1412072026-05-31
M711511412120Endeavor™ Stand-Alone Cervical51-1412122026-05-31
M711511606070Endeavor™ Stand-Alone Cervical51-1606072026-05-31
M711511607070Endeavor™ Stand-Alone Cervical51-1607072026-05-31
M711511607120Endeavor™ Stand-Alone Cervical51-1607122026-05-31
M711511608070Endeavor™ Stand-Alone Cervical51-1608072026-05-31
M711511608120Endeavor™ Stand-Alone Cervical51-1608122026-05-31
M711511609070Endeavor™ Stand-Alone Cervical51-1609072026-05-31
M711511609120Endeavor™ Stand-Alone Cervical51-1609122026-05-31
M711511610070Endeavor™ Stand-Alone Cervical51-1610072026-05-31
M711511610120Endeavor™ Stand-Alone Cervical51-1610122026-05-31
M711511611070Endeavor™ Stand-Alone Cervical51-1611072026-05-31
M711511611120Endeavor™ Stand-Alone Cervical51-1611122026-05-31
M711511612070Endeavor™ Stand-Alone Cervical51-1612072026-05-31
M711511612120Endeavor™ Stand-Alone Cervical51-1612122026-05-31
M711511806070Endeavor™ Stand-Alone Cervical51-1806072026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986490742BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490759BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490766BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490773BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490780BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490797BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490803BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490810BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490827BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490834BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490841BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490858BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490865BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490872BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490889BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490896BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490902BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490919BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490926BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490933BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490940BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490957BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490964BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490971BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490988BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490995BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
00810017913657Saber-C Body (PT), 12x15x6 6 deg.ELEVATION SPINE, INC.ODP2026-06-01
07640140433363icotec Lumbar Cage, Slotted Hammericotec AGODP2018-07-16
07640140433783icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2018-07-16
07640140433790icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2018-07-16