FDA.reportPublic FDA data

M6-C

Primary DI
00812388031145
Brand
M6-C
Company
Spinal Kinetics, Inc.
Model
FA 0207-01
Catalog number
CIC-615-07
Device description
Fin Cutter, 6M (6mm 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
QLQManual Instruments Designed For Total Disc Replacement Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLQManual Instruments Designed For Use With Total Disc Replacement DevicesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812388031145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812388031145008123880311458123880311450812388031145

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
00812388031077M6-CFA 0208-02CTH-715-072022-09-22
00812388031084M6-CFA 0208-03CTH-615L-072022-09-22
00812388031091M6-CFA 0208-04CTH-715L-072022-09-22
00812388031107M6-CFA 0208-05CTH-617-072022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843193115300Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115317Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115324Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115331Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115348Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115355Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115362Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115379Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115386Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
07640139343079BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370525BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370532BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370549BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370556BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370563BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370570BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370587BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370594BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370600BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370617BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370624BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370631BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370648BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370655BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370877BAGUERA® CSpineArt SAQLQ2026-08-19
00843193111838Prodisc L InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112323Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112330Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112347Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112354Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08