FDA.reportPublic FDA data

M6-C

Primary DI
00812388031077
Brand
M6-C
Company
Spinal Kinetics, Inc.
Model
FA 0208-02
Catalog number
CTH-715-07
Device description
Trial Head, 7M (7mm H x 15mm W x 12.5mm D), G7
Published
2022-09-22
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
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812388031077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812388031077008123880310778123880310770812388031077

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
171513125
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812388032517M6-C1503-1000.90CIK-100-082024-09-09
00812388032524M6-C1503-2010.90CIK-201-082024-09-09
00812388032531M6-C1503-2020.90CIK-202-082024-09-09
00812388032548M6-C1503-2030.90CIK-203-082024-09-09
00812388032555M6-C1503-2040.90CIK-204-082024-09-09
00812388032562M6-C1503-2050.90CIK-205-082024-09-09
00812388032579M6-C1503-2060.90CIK-206-082024-09-09
00812388032586M6-C1503-2070.90CIK-207-082024-09-09
00812388032593M6-C1503-2080.90CIK-208-082024-09-09
00812388032609M6-C1503-4100.90CIK-300-082024-09-09
00812388032616M6-CPK 0329CIT-400-082024-09-09
00812388032623M6-CFG 0181CIK-400-082024-09-09
00812388031022M6-CFG 0167CIK-200-072022-09-22
00812388031039M6-CFA 0189CUH-100-072022-09-22
00812388031046M6-CFA 0190CSA-100-072022-09-22
00812388031060M6-CFA 0208-01CTH-615-072022-09-22
00812388031084M6-CFA 0208-03CTH-615L-072022-09-22
00812388031091M6-CFA 0208-04CTH-715L-072022-09-22
00812388031107M6-CFA 0208-05CTH-617-072022-09-22
00812388031114M6-CFA 0208-06CTH-717-072022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04048844758295EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758776n/aimplantcast GmbHHWT2026-06-02
04048844758820n/aimplantcast GmbHHWT2026-06-02
04048844758950n/aimplantcast GmbHHWT2026-06-02
04048844770747n/aimplantcast GmbHHWT2026-06-02
04048844770808n/aimplantcast GmbHHWT2026-06-02
04048844770891n/aimplantcast GmbHHWT2026-06-02
04048844770938n/aimplantcast GmbHHWT2026-06-02
04048844770952n/aimplantcast GmbHHWT2026-06-02
04048844770976n/aimplantcast GmbHHWT2026-06-02
00850011453544REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCHWT2026-06-01
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10603295555582ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
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