M6-C CII-678L-06

GUDID 00812388030414

Inserter, L, G6

Spinal Kinetics, Inc.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00812388030414
NIH Device Record Key46a4a5c6-630a-4f6c-9f91-78057c19e2a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameM6-C
Version Model NumberFA 0194-03
Catalog NumberCII-678L-06
Company DUNS171513125
Company NameSpinal Kinetics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS100812388030414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJOProsthesis, Intervertebral Disc
QLQManual Instruments Designed For Total Disc Replacement Device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00812388030414]

Moist Heat or Steam Sterilization


[00812388030414]

Moist Heat or Steam Sterilization


[00812388030414]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-03-01

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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