FDA.reportPublic FDA data

M6-C

Primary DI
00812388032609
Brand
M6-C
Company
Spinal Kinetics, Inc.
Model
1503-4100.90
Catalog number
CIK-300-08
Device description
M6-C Single Use, Disposable Instrumentation: Mallet
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QLQManual Instruments Designed For Use With Total Disc Replacement Devices

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241117000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241117000M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine2024-06-21QLQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812388032609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812388032609008123880326098123880326090812388032609

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
171513125
Device count
1
Lot or batch
true
Expiration date on label
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
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
00812388031114M6-CFA 0208-06CTH-717-072022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00843193112361Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119926Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119933Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119940Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119957Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119964Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119971Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119988Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119995Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193120007Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
M670107751700Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670107751900Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100000101Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021205Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021407Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021609Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000022206Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000022408Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100000303Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100000707Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000080109Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000008020Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009150Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009160Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009250Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17