| Primary Device ID | 00673978063959 |
| NIH Device Record Key | 1d34ec8a-44e6-4c6e-aa14-20dcd2ba6884 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Colorado 2™ Spinal System |
| Version Model Number | 8612265 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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 | true |
| 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 |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00673978063959 [Primary] |
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
[00673978063959]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-08-24 |
| 00613994125354 | HOOK X335010 06.35 CLOSED LAMINAR |
| 00673978953373 | STAPLE 8639400 ANTERIOR |
| 00673978953366 | SCREW 8639300 L AND ILIO L SET |
| 00673978953236 | CONNECTOR 8635430 LATERAL CLOSED |
| 00673978953212 | SCREW 8635405 BREAK OFF LOCKING |
| 00673978953205 | CONNECTOR 8635400 5.5X5.5 LAT CLOSE CLMP |
| 00673978953199 | CONNECTOR 8634200 OFFSET CLAMP |
| 00673978953168 | CONNECTOR 8634110 SACRAL ILIO PLATE |
| 00673978953144 | CLIP 8634100 FOR 5.5MM ROD |
| 00673978952901 | 7.5MM SCREW X 60MM |
| 00673978952635 | SCREW 8632370 CLRD SACRAL 7.0X70MM |
| 00673978952628 | SCREW 8632365 CLRD SACRAL 7.0X65MM |
| 00673978952611 | SCREW 8632360 CLRD SACRAL 7.0X60MM |
| 00673978952604 | SCREW 8632355 CLRD SACRAL 7.0X55MM |
| 00673978952598 | SCREW 8632350 CLRD SACRAL 7.0X50MM |
| 00673978952581 | SCREW 8632345 CLRD SACRAL 7.0X45MM |
| 00673978952574 | SCREW 8632340 CLRD SACRAL 7.0X40MM |
| 00673978952567 | SCREW 8632335 CLRD SACRAL 7.0X35MM |
| 00673978952550 | SCREW 8632330 CLRD SACRAL 7.0X30MM |
| 00673978952543 | SCREW 8632270 CLRD SACRAL 6.5X70MM |
| 00673978952536 | SCREW 8632265 CLRD SACRAL 6.5X65MM |
| 00673978952529 | SCREW 8632260 CLRD SACRAL 6.5X60MM |
| 00673978952512 | SCREW 8632255 CLRD SACRAL 6.5X55MM |
| 00673978952505 | SCREW 8632250 CLRD SACRAL 6.5X50MM |
| 00673978952499 | SCREW 8632245 CLRD SACRAL 6.5X45MM |
| 00673978952482 | SCREW 8632240 CLRD SACRAL 6.5X40MM |
| 00673978952475 | SCREW 8632235 CLRD SACRAL 6.5X35MM |
| 00673978952468 | SCREW 8632230 CLRD SACRAL 6.5X30MM |
| 00673978952451 | SCREW 8632080 CLRD ILIO SACRAL 7.0X80MM |
| 00673978952444 | SCREW 8632075 CLRD ILIO SACRAL 7.0X75MM |
| 00673978952437 | SCREW 8632070 CLRD ILIO SACRAL 7.0X70MM |
| 00673978952420 | SCREW 8632065 CLRD ILIO SACRAL 7.0X65MM |
| 00673978952413 | SCREW 8632060 CLRD ILIO SACRAL 7.0X60MM |
| 00673978952406 | SCREW 8632055 CLRD ILIO SACRAL 7.0X55MM |
| 00673978952390 | SCREW 8632050 CLRD ILIO SACRAL 7.0X50MM |
| 00673978952376 | HOOK 8631402 CLOSED LAMINAR THORACIC |
| 00673978952369 | STAPLE 8631300 |
| 00673978952352 | HOOK 8631204 LARGE LAMINAR |
| 00673978952345 | HOOK 8631203 MEDIUM LAMINAR |
| 00673978952338 | HOOK 8631202 SMALL LAMINAR |
| 00673978952321 | HOOK 8631104 LARGE PEDICLE |
| 00673978952314 | HOOK 8631102 SMALL PEDICLE |
| 00673978952185 | SCREW 8630650 CLRD 6.5MMX50MM |
| 00673978952178 | SCREW 8630645 CLRD 6.5MMX45MM |
| 00673978952116 | SCREW 8630550 CLRD 5.5MMX50MM |
| 00673978952093 | SCREW 8630540 CLRD 5.5MMX40MM |
| 00673978951959 | PLATE 8619654 INTERPEDICULAR 54MM |
| 00673978951683 | CONNECTOR 8614200 OFFSET |
| 00673978951645 | SCREW 8612230 CLRD SACRAL 6.5X30MM |
| 00673978951515 | SCREW 8610765 CLRD 7.5MMX65MM |