CAPSTONE PTC™ Spinal System
GUDID 00643169187450
SPACER 3992607 26MM X 7MM
MEDTRONIC SOFAMOR DANEK, INC.
Polymeric spinal fusion cage, sterile| Primary Device ID | 00643169187450 |
| NIH Device Record Key | 2e166f2f-bc39-4b4f-a9a0-8cfce935a86f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CAPSTONE PTC™ Spinal System |
| Version Model Number | 3992607 |
| 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 | false |
| 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
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169187450 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133205
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 | 2016-04-17 |
On-Brand Devices [CAPSTONE PTC™ Spinal System]
| 00643169187573 | SPACER 3992206 22MM X 6MM |
| 00643169187566 | SPACER 3992207 22MM X 7MM |
| 00643169187559 | SPACER 3992208 22MM X 8MM |
| 00643169187542 | SPACER 3992209 22MM X 9MM |
| 00643169187535 | SPACER 3992210 22MM X 10MM |
| 00643169187528 | SPACER 3992211 22MM X 11MM |
| 00643169187511 | SPACER 3992212 22MM X 12MM |
| 00643169187504 | SPACER 3992213 22MM X 13MM |
| 00643169187498 | SPACER 3992214 22MM X 14MM |
| 00643169187481 | SPACER 3992215 22MM X 15MM |
| 00643169187474 | SPACER 3992216 22MM X 16MM |
| 00643169187467 | SPACER 3992606 26MM X 6MM |
| 00643169187450 | SPACER 3992607 26MM X 7MM |
| 00643169187443 | SPACER 3992608 26MM X 8MM |
| 00643169187436 | SPACER 3992609 26MM X 9MM |
| 00643169187429 | SPACER 3992610 26MM X 10MM |
| 00643169187412 | SPACER 3992611 26MM X 11MM |
| 00643169187405 | SPACER 3992612 26MM X 12MM |
| 00643169187399 | SPACER 3992613 26MM X 13MM |
| 00643169187382 | SPACER 3992614 26MM X 14MM |
| 00643169187375 | SPACER 3992615 26MM X 15MM |
| 00643169187368 | SPACER 3992616 26MM X 16MM |
| 00643169187351 | SPACER 3993207 32MM X 7MM |
| 00643169187344 | SPACER 3993208 32MM X 8MM |
| 00643169187337 | SPACER 3993209 32MM X 9MM |
| 00643169187320 | SPACER 3993210 32MM X 10MM |
| 00643169187313 | SPACER 3993211 32MM X 11MM |
| 00643169187306 | SPACER 3993212 32MM X 12MM |
| 00643169187290 | SPACER 3993213 32MM X 13MM |
| 00643169187283 | SPACER 3993214 32MM X 14MM |
| 00643169187276 | SPACER 3993215 32MM X 15MM |
| 00643169187269 | SPACER 3993216 32MM X 16MM |
| 00643169187252 | SPACER 3993607 36MM X 7MM |
| 00643169187245 | SPACER 3993608 36MM X 8MM |
| 00643169187238 | SPACER 3993609 36MM X 9MM |
| 00643169187221 | SPACER 3993610 36MM X 10MM |
| 00643169187214 | SPACER 3993611 36MM X 11MM |
| 00643169187207 | SPACER 3993612 36MM X 12MM |
| 00643169187191 | SPACER 3993613 36MM X 13MM |
| 00643169187184 | SPACER 3993614 36MM X 14MM |
| 00643169187177 | SPACER 3993615 36MM X 15MM |
| 00643169187160 | SPACER 3993616 36MM X 16MM |
Trademark Results [CAPSTONE PTC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPSTONE PTC 85622851 4863474 Live/Registered |
Medtronic, Inc. 2012-05-11 |
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