M6-C ICC-0000-20

GUDID 00812388031305

M6-C Implant Case Kit – Standard

Spinal Kinetics, Inc.

Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular
Primary Device ID00812388031305
NIH Device Record Key4d63ce9f-642e-46e1-b7d7-f1164fce6b58
Commercial Distribution StatusIn Commercial Distribution
Brand NameM6-C
Version Model NumberFG 0168
Catalog NumberICC-0000-20
Company DUNS171513125
Company NameSpinal Kinetics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812388031305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJOProsthesis, Intervertebral Disc

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-28
Device Publish Date2022-04-20

On-Brand Devices [M6-C]

00812388030087Artificial Cervical Disc, 7LL (7mm H x 17mm W x 16mm D)
00812388030070Artificial Cervical Disc, 7L (7mm H x 17mm W x 14mm D)
00812388030063Artificial Cervical Disc, 7ML (7mm H x 15mm W x 15mm D)
00812388030056Artificial Cervical Disc, 7M (7mm H x 15mm W x 12.5mm D)
00812388030049Artificial Cervical Disc, 6LL (6mm H x 17mm W x 16mm D)
00812388030032Artificial Cervical Disc, 6L (6mm H x 17mm W x 14mm D)
00812388030025Artificial Cervical Disc, 6ML (6mm H x 15mm W x 15mm D)
00812388030018Artificial Cervical Disc, 6M (6mm H x 15mm W x 12.5mm D)
00812388030476Instrument Kit, G6
00812388030469Instrument Tray, SS, G6
00812388030452Acute Disc Removal Tool, L/LL, G6
00812388030445Acute Disc Removal Tool, M/ML, G6
00812388030438Offset Tamp, G6
00812388030421Inserter, LL, G6
00812388030414Inserter, L, G6
00812388030407Inserter, ML, G6
00812388030391Inserter, M, G6
00812388030384Slide Hammer, G6
00812388030377Fin Cutter, 7LL (7mm H x 17mm W x 16mm D), G6
00812388030360Fin Cutter, 7L (7mm H x 17mm W x 14mm D), G6
00812388030353Fin Cutter, 7ML (7mm H x 15mm W x 15mm D), G6
00812388030346Fin Cutter, 7M (7mm H x 15mm W x 12.5mm D), G6
00812388030339Fin Cutter, 6LL (6mm H x 17mm W x 16mm D), G6
00812388030322Fin Cutter, 6L (6mm H x 17mm W x 14mm D), G6
00812388030315Fin Cutter, 6ML (6mm H x 15mm W x 15mm D), G6
00812388030308Fin Cutter, 6M (6mm H x 15mm W x 12.5mm D), G6
00812388030292Mallet, G6
00812388030285Trial Handle, G6
00812388030278Trial Head, 7LL (7mm H x 17mm W x 16mm D), G6
00812388030261Trial Head, 7L (7mm H x 17mm W x 14mm D), G6
00812388030254Trial Head, 7ML (7mm H x 15mm W x 15mm D), G6
00812388030247Trial Head, 7M (7mm H x 15mm W x 12.5mm D), G6
00812388030230Trial Head, 6LL (6mm H x 17mm W x 16mm D), G6
00812388030223Trial Head, 6L (6mm H x 17mm W x 14mm D), G6
00812388030216Trial Head, 6ML (6mm H x 15mm W x 15mm D), G6
00812388030209Trial Head, 6M (6mm H x 15mm W x 12.5mm D), G6
00812388030193Footprint Template, L/LL, G6
00812388030186Footprint Template, M/ML, G6
00812388030179Intervertebral Distractor, G6
00812388030162Distractor Spacer, G6
00812388030155Paddle Distractor, G6
00812388030148Cervical Retainer Locking Nut
00812388030131Retainer, G6
00812388030124Pin Driver, G6
00812388030117Cervical Retainer Pin, 16mm
00812388030100Cervical Retainer Pin, 14mm
00812388030094Cervical Retainer Pin, 12mm
00812388031312M6-C Implant Case Kit – Ancillary
00812388031305M6-C Implant Case Kit – Standard
00812388031299Instrument Tray, SS, G7

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