| Primary Device ID | 00812388030278 |
| NIH Device Record Key | def76b30-ef26-4073-803b-210a0d1266b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M6-C |
| Version Model Number | FA 0192-08 |
| Catalog Number | CTH-717L-06 |
| Company DUNS | 171513125 |
| Company Name | Spinal Kinetics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812388030278 [Primary] |
| HWT | Template |
| MJO | Prosthesis, Intervertebral Disc |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00812388030278]
Moist Heat or Steam Sterilization
[00812388030278]
Moist Heat or Steam Sterilization
[00812388030278]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-03-01 |
| 00812388030087 | Artificial Cervical Disc, 7LL (7mm H x 17mm W x 16mm D) |
| 00812388030070 | Artificial Cervical Disc, 7L (7mm H x 17mm W x 14mm D) |
| 00812388030063 | Artificial Cervical Disc, 7ML (7mm H x 15mm W x 15mm D) |
| 00812388030056 | Artificial Cervical Disc, 7M (7mm H x 15mm W x 12.5mm D) |
| 00812388030049 | Artificial Cervical Disc, 6LL (6mm H x 17mm W x 16mm D) |
| 00812388030032 | Artificial Cervical Disc, 6L (6mm H x 17mm W x 14mm D) |
| 00812388030025 | Artificial Cervical Disc, 6ML (6mm H x 15mm W x 15mm D) |
| 00812388030018 | Artificial Cervical Disc, 6M (6mm H x 15mm W x 12.5mm D) |
| 00812388030476 | Instrument Kit, G6 |
| 00812388030469 | Instrument Tray, SS, G6 |
| 00812388030452 | Acute Disc Removal Tool, L/LL, G6 |
| 00812388030445 | Acute Disc Removal Tool, M/ML, G6 |
| 00812388030438 | Offset Tamp, G6 |
| 00812388030421 | Inserter, LL, G6 |
| 00812388030414 | Inserter, L, G6 |
| 00812388030407 | Inserter, ML, G6 |
| 00812388030391 | Inserter, M, G6 |
| 00812388030384 | Slide Hammer, G6 |
| 00812388030377 | Fin Cutter, 7LL (7mm H x 17mm W x 16mm D), G6 |
| 00812388030360 | Fin Cutter, 7L (7mm H x 17mm W x 14mm D), G6 |
| 00812388030353 | Fin Cutter, 7ML (7mm H x 15mm W x 15mm D), G6 |
| 00812388030346 | Fin Cutter, 7M (7mm H x 15mm W x 12.5mm D), G6 |
| 00812388030339 | Fin Cutter, 6LL (6mm H x 17mm W x 16mm D), G6 |
| 00812388030322 | Fin Cutter, 6L (6mm H x 17mm W x 14mm D), G6 |
| 00812388030315 | Fin Cutter, 6ML (6mm H x 15mm W x 15mm D), G6 |
| 00812388030308 | Fin Cutter, 6M (6mm H x 15mm W x 12.5mm D), G6 |
| 00812388030292 | Mallet, G6 |
| 00812388030285 | Trial Handle, G6 |
| 00812388030278 | Trial Head, 7LL (7mm H x 17mm W x 16mm D), G6 |
| 00812388030261 | Trial Head, 7L (7mm H x 17mm W x 14mm D), G6 |
| 00812388030254 | Trial Head, 7ML (7mm H x 15mm W x 15mm D), G6 |
| 00812388030247 | Trial Head, 7M (7mm H x 15mm W x 12.5mm D), G6 |
| 00812388030230 | Trial Head, 6LL (6mm H x 17mm W x 16mm D), G6 |
| 00812388030223 | Trial Head, 6L (6mm H x 17mm W x 14mm D), G6 |
| 00812388030216 | Trial Head, 6ML (6mm H x 15mm W x 15mm D), G6 |
| 00812388030209 | Trial Head, 6M (6mm H x 15mm W x 12.5mm D), G6 |
| 00812388030193 | Footprint Template, L/LL, G6 |
| 00812388030186 | Footprint Template, M/ML, G6 |
| 00812388030179 | Intervertebral Distractor, G6 |
| 00812388030162 | Distractor Spacer, G6 |
| 00812388030155 | Paddle Distractor, G6 |
| 00812388030148 | Cervical Retainer Locking Nut |
| 00812388030131 | Retainer, G6 |
| 00812388030124 | Pin Driver, G6 |
| 00812388030117 | Cervical Retainer Pin, 16mm |
| 00812388030100 | Cervical Retainer Pin, 14mm |
| 00812388030094 | Cervical Retainer Pin, 12mm |
| 00812388031312 | M6-C Implant Case Kit – Ancillary |
| 00812388031305 | M6-C Implant Case Kit – Standard |
| 00812388031299 | Instrument Tray, SS, G7 |