FDA.reportPublic FDA data

TALOS®-C

Primary DI
B167509313306140
Brand
TALOS®-C
Company
MEDITECH SPINE, LLC
Model
509-313306-14
Published
2022-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K142345000
K150788000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142345000Talos-C(HA) Cervical Intervertebral Body Fusion DevicesMeditech Spine, LLC2015-02-22ODP
K150788000Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion DevicesMeditech Spine, LLC2015-10-14ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B167509313306140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
182698477
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B167900002250CURE IVIEW9-00002-252022-10-07
B167900002260CURE IVIEW9-00002-262022-10-07
B167900002270CURE IVIEW9-00002-272022-10-07
B167900002280CURE IVIEW9-00002-282022-10-07
B167900002290CURE IVIEW9-00002-292022-10-07
B167900002300CURE IVIEW9-00002-302022-10-07
B167900002310CURE IVIEW9-00002-312022-10-07
B167900002320CURE IVIEW9-00002-322022-10-07
B167900002330CURE IVIEW9-00002-332022-10-07
B167900002340CURE IVIEW9-00002-342022-10-07
B167900002350CURE IVIEW9-00002-352022-10-07
B167900002360CURE IVIEW9-00002-362022-10-07
B167900002370CURE IVIEW9-00002-372022-10-07
B167900002380CURE IVIEW9-00002-382022-10-07
B167900002390CURE IVIEW9-00002-392022-10-07
B167900002400CURE IVIEW9-00002-402022-10-07
B167900002410CURE IVIEW9-00002-412022-10-07
B167900002420CURE IVIEW9-00002-422022-10-07
B167900002430CURE IVIEW9-00002-432022-10-07
B167900002440CURE IVIEW9-00002-442022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.ODP2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.ODP2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.ODP2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.ODP2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.ODP2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.ODP2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.ODP2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.ODP2026-06-05
08809986491008BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491015BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491022BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491039BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491046BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491053BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491060BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491077BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491084BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491091BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491107BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491114BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491121BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491138BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
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