CAPSTONE CONTROL™ Spinal System
GUDID 00643169108936
SPACER 4021627 18 DEG 16X27
MEDTRONIC SOFAMOR DANEK, INC.
Polymeric spinal fusion cage, sterile| Primary Device ID | 00643169108936 |
| NIH Device Record Key | 8df029d1-a27a-4a6a-a905-6ce118a94c20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CAPSTONE CONTROL™ Spinal System |
| Version Model Number | 4021627 |
| 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 |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Angle | 18 degree |
| Angle | 18 degree |
| Angle | 18 degree |
| Angle | 18 degree |
| Angle | 18 degree |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
| Length | 27 Millimeter |
| Outer Diameter | 16 Millimeter |
| Angle | 18 degree |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169108936 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120368
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-06-25 |
On-Brand Devices [CAPSTONE CONTROL™ Spinal System]
| 00643169109827 | SPACER 4001427 6 DEG 14X27 |
| 00643169109810 | SPACER 4001422 6 DEG 14X22 |
| 00643169109803 | SPACER 4001332 6 DEG 13X32 |
| 00643169109797 | SPACER 4001327 6 DEG 13X27 |
| 00643169109780 | SPACER 4001322 6 DEG 13X22 |
| 00643169109773 | SPACER 4001232 6 DEG 12X32 |
| 00643169109766 | SPACER 4001227 6 DEG 12X27 |
| 00643169109759 | SPACER 4001222 6 DEG 12X22 |
| 00643169109742 | SPACER 4001132 6 DEG 11X32 |
| 00643169109735 | SPACER 4001127 6 DEG 11X27 |
| 00643169109728 | SPACER 4001122 6 DEG 11X22 |
| 00643169109711 | SPACER 4001027 6 DEG 10X27 |
| 00643169109704 | SPACER 4001022 6 DEG 10X22 |
| 00643169109667 | SPACER 4001732 6 DEG 17X32 |
| 00643169109650 | SPACER 4001727 6 DEG 17X27 |
| 00643169109643 | SPACER 4001722 6 DEG 17X22 |
| 00643169109636 | SPACER 4001632 6 DEG 16X32 |
| 00643169109629 | SPACER 4001627 6 DEG 16X27 |
| 00643169109612 | SPACER 4001622 6 DEG 16X22 |
| 00643169109605 | SPACER 4001532 6 DEG 15X32 |
| 00643169109599 | SPACER 4001527 6 DEG 15X27 |
| 00643169109582 | SPACER 4001522 6 DEG 15X22 |
| 00643169109575 | SPACER 4001432 6 DEG 14X32 |
| 00643169109094 | SPACER 4021622 18 DEG 16X22 |
| 00643169109087 | SPACER 4021522 18 DEG 15X22 |
| 00643169109070 | SPACER 4011222 12 DEG 12X22 |
| 00643169109063 | SPACER 4011122 12 DEG 11X22 |
| 00643169109056 | SPACER 4011022 12 DEG 10X22 |
| 00643169109049 | SPACER 4021422 18 DEG 14X22 |
| 00643169109032 | SPACER 4021322 18 DEG 13X22 |
| 00643169109018 | SPACER 4011722 12 DEG 17X22 |
| 00643169109001 | SPACER 4011622 12 DEG 16X22 |
| 00643169108998 | SPACER 4011522 12 DEG 15X22 |
| 00643169108981 | SPACER 4011422 12 DEG 14X22 |
| 00643169108974 | SPACER 4011322 12 DEG 13X22 |
| 00643169108967 | SPACER 4021722 18 DEG 17X22 |
| 00643169108943 | SPACER 4021727 18 DEG 17X27 |
| 00643169108936 | SPACER 4021627 18 DEG 16X27 |
| 00643169108929 | SPACER 4021527 18 DEG 15X27 |
| 00643169108912 | SPACER 4021427 18 DEG 14X27 |
| 00643169108899 | SPACER 4011727 12 DEG 17X27 |
| 00643169108882 | SPACER 4011627 12 DEG 16X27 |
| 00643169108875 | SPACER 4011527 12 DEG 15X27 |
| 00643169108868 | SPACER 4011427 12 DEG 14X27 |
| 00643169108851 | SPACER 4011327 12 DEG 13X27 |
| 00643169108844 | SPACER 4011227 12 DEG 12X27 |
| 00643169092129 | TRAY 3990052 SPREADER TRIALS- 2 |
| 00643169092112 | TRAY 3990051 SPREADER TRIALS- 1 |
| 00643169092105 | TRAY 3990050 GENERAL INSTRUMENTS |
| 00643169055759 | SPACER 3991327 CAPSTONE IR 0 DEG 13X27 |
Trademark Results [CAPSTONE CONTROL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPSTONE CONTROL 85253149 4324898 Live/Registered |
Medtronic, Inc. 2011-02-28 |
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